Time to Panic? Telemedicine and Controlled Substances: The DEA’s Proposed Rule
by Dr. Hillary Lin
This is Janet. By the time we met in my clinic, she was so depressed she couldn’t leave her home. I tried half a dozen medications in various combinations with her to no avail. And then we tried ketamine-assisted coaching. Within weeks, she was leaving her house with her husband to run errands, and even occasionally meeting up with friends. She started exploring deeper emotional concepts such as identity and confidence in her coaching sessions.
I was able to start ketamine-assisted treatment for Janet because of the telemedicine flexibilities introduced in recent years. Her inability to leave her home in her darkest hour meant she would never have been able to start getting treatment for her mental health otherwise.
Death of 100s of telemedicine startups?
The DEA’s new proposed rule for telemedicine prescription of controlled substances is the hot topic of the day in healthcare. There are dozens, if not hundreds, of companies today whose many value proposition is to offer prescriptions for controlled substances via telemedicine. This boom occurred primarily due to the COVID public health emergency flexibilities which removed certain licensing barriers and the requirement for an in-person medical exam prior to prescription.
The new DEA proposed rule would nix that latter flexibility by forcing a limitation of 30-day supply before an in-person exam is required. Founders and investors of the telemedicine startups offering controlled substances are experiencing a panic (perhaps not dissimilar to Google’s panic as they see swathes of search engine users move to Bing AI).
As a physician co-founder of a company which promotes and offers virtual ketamine/psychedelic care, and one who deeply understands the plight of patients such as Janet, my feelings about the new rule are mixed. There is a large part of me that is grateful for some restrictions to be put in place for telemedicine practices. Both startups and traditional clinics often fall into the trap of cutting corners to increase profits in the ketamine space. The way it’s being prescribed by such clinics makes ketamine less helpful to the patient because there is so little structure around the experience. A lot of newcomers to psychedelics wind up with diluted outcomes due to the pill mill nature of high volume, low human-touch platforms. They never get to experience the transformative potential of therapeutic psychedelic treatment and may even give up on yet another modality that failed to treat their mental health condition.
Yet the devil is in the details for the proposed rule. Let’s dive more deeply into a (very short) history lesson about how things came to be here.
A path paved with good intentions
The Ryan Haight Online Pharmacy Consumer Protection Act was passed in 2008 to regulate the sale of controlled substances over the internet. It was named after Ryan Haight, a teenager who died of a drug overdose after obtaining prescription drugs online. The act defines several requirements for controlled substance prescription and sale, most relevantly the requirement for an in-person medical exam by the DEA-licensed clinician before they write a controlled substance prescription for each patient. Over 100,000 Americans died in a drug overdose in 2021, with >70% coming from synthetic opioids (such as fentanyl) alone, so it’s not clear that these requirements alone have been successful in meaningfully decreasing such tragedies. You can see in this chart below that much of the recent increase in overdose deaths resulted from non-prescription opioids (while prescription opioids led to a stable and even slightly declining number of overdose deaths before the pandemic).
As mentioned previously, the Public Health Emergency declared during the COVID pandemic allowed certain prescribing flexibilities, including the waiver of the in-person medical exam requirement. As the PHE is about to end on May 11, 2023, the DEA has proposed a rule to bridge the gap between the current status quo and the original RHA. The hope is that the rule would reintroduce certain requirements which would check the rise of controlled substance abuse without creating too much of a barrier for those in need.
The reality check
While the rule’s intent is commendable, its practical implications pose a challenge to patients with mental health conditions who may struggle to access in-person medical care due to their emotional symptoms and even socioeconomic reasons. My patient Janet was actually lucky enough to have a supportive husband who could theoretically drive her to an in-person doctor’s appointment if she had been feeling well enough to do so. I have had hundreds of other patients who did not have the resources or support system to find, much less go to, an in-person mental health clinic. In many cases, these reasons are the very ones causing the severity of their mental health symptoms, leading to a terrible vicious cycle.
Unless the US healthcare system will suddenly ramp up its public health and social work efforts such that we can send doctors to mental health patients’ homes or otherwise drive them to appointments, we’re going to have a major problem here. It is essential to strike a balance between preventing controlled substance misuse and ensuring patient access to proper mental health care. I believe the DEA proposed rule is well-meaning but will play out in an unfortunate way for those most in need.
A different way
I founded Curio to help those like Janet get better more quickly and stay better for much longer. We offer an end-to-end patient journey experience that is supported at every step of the way because mental health patients are the ones most in need of such guidance. We’ve already invested significant effort into creating the most optimal structure around every ketamine session, and our clinic can work with the proposed rule to offer the very best initial sessions even with a 30-day limitation on ketamine prescriptions. We are also developing additional mental health navigational support features which we’re launching soon to help patients sooner and more completely in their journey. These care navigation and delivery features mean our core business will survive and even thrive with the regulatory changes, but I am still worried for the patients who cannot make it to in-person visits.
I believe there’s a better version of the proposed DEA rule, one that uses technology to its fullest potential.
Using technology to prevent misuse
We are currently living in a technology-driven era where AI is disrupting almost every industry, including healthcare. Despite the fact that the healthcare industry has been hesitant to adopt new technologies due to cultural reasons, signs of acceptance and appreciation of AI are beginning to surface, as indicated by the FDA’s increasing approval of AI- and machine learning-enabled medical devices.
The integration of AI and other technology-enabled automations can greatly aid in the management of controlled substance distribution and usage. For instance, the existing Prescription Drug Monitoring Programs (PDMPs) can be enhanced and made more user-friendly for healthcare practitioners, enabling early detection of anomalies in prescribing patterns. By monitoring the prescription of controlled substances to individual patients from multiple providers, the likelihood of diversion or overuse can be minimized. Automated tracking of controlled substances from the laboratory to the pharmacy to the patient can also be implemented. This would allow for real-time monitoring of the drug’s path and better information about potential abuse. Furthermore, automated analysis of outcomes from using controlled substances can be incorporated so as to reduce practitioner dependence on mindless refills and streamline the prescription process to maximize efficacy and minimize patient risk.
Remote patient monitoring technology can also provide a solution to the problem of controlled substance diversion and abuse. It enables healthcare providers to track patients’ medication use and detect any signs of misuse, regardless of whether the medical examination took place in-person or via telemedicine. We have developed our own in-house system for doing such monitoring, and as a result feel very secure in our patients’ safety and support. By utilizing this technology, we can ensure that patients have access to the care they need while preventing controlled substance misuse.
These processes are not technically difficult or even foreign to people living in today’s world. We have remote patient monitoring systems set in place for a variety of medical use cases. The simplest include sleep journals and blood pressure cuff readings in between clinic visits. More advanced versions include remote ICUs where critically ill patients are monitored and managed from hundreds of miles away.
All these tech-enabled methods would better-align with the needs of mental health patients. It would certainly be a shift in the way we approach healthcare in the US — a shift for the better. We must adopt a comprehensive approach to address the root causes of mental health conditions and substance use disorders. Our healthcare system should shift towards a patient-centric model that considers the whole patient, including their physical, emotional, and spiritual needs. By doing so, we can provide more effective and accessible care to those in need.
A step into the future
The DEA’s proposed rule for telemedicine prescription of controlled substances is a step in the right direction towards preventing controlled substance misuse. However, we must balance this with patient access to care, especially for those who may struggle to access in-person medical care. By utilizing remote patient monitoring technology and AI-augmented systems, plus adopting a more holistic and comprehensive approach to healthcare, we can ensure that patients receive effective and accessible care while preventing controlled substance diversion and misuse.
Centers for Disease Control and Prevention. (2021, May 19). Prescription Drug Monitoring Programs (pdmps). Centers for Disease Control and Prevention. Retrieved March 6, 2023, from https://www.cdc.gov/drugoverdose/pdmp/index.html
Lin, H. (2023, February 3). Deep Healthcare — an innovative path to true holistic health. Medium. Retrieved March 6, 2023, from https://medium.com/joincurio/deep-healthcare-an-innovative-path-to-true-holistic-health-68d798c77378
Reuter, E. (2022, November 7). 5 takeaways from the FDA’s list of Ai-Enabled Medical Devices. MedTech Dive. Retrieved March 6, 2023, from https://www.medtechdive.com/news/FDA-AI-ML-medical-devices-5-takeaways/635908/
U.S. Department of Health and Human Services. (2023, February 24). Drug overdose death rates. National Institutes of Health. Retrieved March 5, 2023, from https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates
US Congress. (2008). Ryan Haight online pharmacy consumer protection act of 2008 — congress. Retrieved March 5, 2023, from https://www.congress.gov/110/plaws/publ425/PLAW-110publ425.pdf