A ReLACSing Blog #24: How the 2023 DEA Telemedicine Proposal Could Impact Patients with Sleep Disorders
As the explosion of telemedicine services ushered in by the COVID-19 pandemic in 2020 has begun to stabilize, the epidemic of poisonings and fatal overdoses from illicit drugs and opioids like fentanyl seems to be headed in the wrong direction. In this backdrop, the Drug Enforcement Administration (DEA) has released a proposal for increased regulations on the prescribing of controlled substances by healthcare providers. Though the document appears to be written in English, I find it so challenging to understand that I am not even sure what its official title is. Let’s call it Docket No. DEA–407. I will address the so-called (by me, but I could be wrong too!) Docket No. DEA–407 and its potential impact on the practice of sleep medicine in the United States.
To avoid breaking the trend of positively themed blog posts about progress in U.S. healthcare, I will refrain from using adjectives like disappointing, misguided, regressive, and onerous this early in this article. Let’s instead start with background information. One of the main roles of the DEA is to regulate the prescribing and dispensing of controlled substances by healthcare providers and pharmacists. Many of these controlled substances are prescription medications for legitimate medical use that have the potential abuse, misuse, and dependence. Drugs are placed in categories called Schedules (pronounced “sheh’-jools” in the U.K. of course) depending on the level of risk and are regulated more strictly the lower the Schedule Roman numeral. Schedule I drugs have no accepted medical use, such as marijuana…errrrrrrr…I think I…just stepped in…it…let’s try another drug…3,4-methylenedioxymethamphetamine (yes, less controversial because the chemical name means nothing to you; let’s call it “ecstasy”). Schedule II would be highly regulated prescription drugs like most opioids (oxycodone, methadone, for example), all the way down to Schedule V drugs that have a very low potential for abuse like pregabalin (Lyrica®), and I will reference this drug later. The Schedule influences the number of hoops through which a doctor must jump to prescribe it, such as reviewing a prescription monitoring database (PDMP), how many refills can be provided, whether a controlled-substance agreement is recommended, etc. The same is true for pharmacies and patients themselves. Giving Aunt Ginny your Schedule II amphetamine to perk her up in the afternoon is probably a bad idea, both from the eyes of safety as well as the DEA who could theoretically come after you. Giving Aunt Ginny your lisinopril is probably a bad idea too, but this is not a controlled substance, and though illegal, you would not be at as much legal risk (1).
It may come as a surprise to you, but the medical field is often slow to adopt new technologies, which is why we still are sending faxes from one doctor’s office to another (and still paper letters via U.S. mail!) as a more “secure” way of transmitting private health information. The same is true for telemedicine, which can be defined numerous ways, but for the sake of this article, it means videoconferencing or real-time audiovisual communication between two parties (think Microsoft Teams or Google Meet). In large part due to the insurance system refusing to reimburse for telemedicine visits prior to the pandemic, medical systems relied on in-person visits as the bread-and-butter method of delivering medical care. You probably remember in-person visits where you have to drive for an hour, spend 15 minutes parking, 15 more minutes trying to find the clinic, 15 minutes checking in, multiples of 15 minutes in the waiting room, 15 minutes waiting in the exam room, and less than 15 minutes in the room with a doctor. Telemedicine emerged as a technology that allowed patients to spend 15 minutes trying to figure out how to connect to Zoom, but then voila!, the doctor was in your kitchen talking to you through video on your smartphone without having to deal with those other 15-minute frustrations. If the doctor was late, you could just continue cooking your omelet until the doctor appeared on screen. It was an amazing breakthrough for the delivery of medical care. Direct care practices had already been doing this for years, probably as long as FaceTime and Skype have existed, because with a reimbursement model of patients paying a monthly fee to the direct care physicians, they were not restricted in having to see their clinic members in person. They could do phone, text, and email as well without taking a financial hit.
In 2008, the DEA created the “Ryan Haight Act” for consumer protection that required prescribers to see a patient in person prior to prescribing controlled substances with some exceptions. Ryan Haight was a high school student who died of a medication poisoning from illicit prescription of a controlled substance from an internet-based pharmacy. It was quite common in the early days of the internet for controlled substances to be prescribed without a legitimate doctor-patient evaluation or relationship. This 2008 policy had been the standard for a dozen years until the pandemic hit with the Public Health Emergency, suddenly making telemedicine widespread with in-person-anything suboptimal. The DEA relaxed controlled substance regulations during the national emergency so much that telemedicine-based prescribing was now commonplace. Doctors could even see patients and prescribe across state lines where the practitioner does not have a state license. For many, including the elderly, those with physical disabilities, residents of rural areas, people who could not afford transportation, workers unable to take time off during an 8—5 weekday, patients needing sub-specialized treatments, and even those with an aversion to 15-minute inconveniences now had practical access to nearly all physicians, potentially in other regions of the country as well. Think of that wheelchair-bound person with a rare hereditary nerve condition who lived in Nome, Alaska. Instead of flying to Seattle to see a specialist every six months, the same doctor in Seattle could prescribe pregabalin for her nerve pain with the patient still at home. This was the scene for a few years with very gradual tightening of telemedicine restrictions by each state up to the present. Now that the Public Health Emergency is coming to an end in May after more than three years, the DEA has decided for a more permanent solution to the question of telemedicine and controlled substance prescribing in the post-COVID era.
Technology enabling the doctor to come right to your home just like in the olden days
I am not a health law expert or a lawyer, and this DEA memo appeared in my email inbox on March 1, 2023, so do not hold the interpretation against me. I actually wish the DEA would have delivered this memo in person, rather than electronically, so I could have asked several questions, though I would have gladly accepted synchronous, audiovisual, real-time communication with a DEA officer as well. Or maybe just a phone call? However, I run a 100% telemedicine clinic delivering treatment in a specialty in which nearly all of the medications are controlled substances, and almost none of my patients could practically see me in person, even if I had a brick and mortar clinic. You would say I am quite interested in the outcome of this policy.
The new proposal would allow Schedule III-V non-narcotic, controlled substances to be prescribed via telemedicine without an in person visit for up to 30 days, but there are some hoops through which to jump after that. Opioids and other Schedule II drugs cannot be prescribed at all without an in-person evaluation first. To prescribe Schedule III-V beyond 30 days or to prescribe a Schedule II medication at all, the telemedicine provider must be present through telemedicine at the same time that the patient is seeing another DEA-licensed practitioner who can perform an in person examination. Coordinating a time for doctors from two clinics to be available at the same time sounds basically impossible, but this is one option. The better option offered is that Dr. In-the-Flesh sees a patient in person, examines the patient, and then sends a referral to Dr. Telemedicine who can then prescribe controlled substances after seeing the patient via telemedicine. I suppose the idea is that Dr. In-the-Flesh can be more certain that the person is real, they have a real condition and they can have a real controlled substance. The DEA states that this process will cut down on illegal drug diversion. Yes, that it is technically correct. It is correct in that if you create enough barriers to obtaining controlled substances, it will reduce the total number of controlled substances prescribed, and this could lower the amount of drugs diverted. But is this an effective strategy for reducing poisonings by imported fentanyl on the street? As we know in medicine, for every intervention, there is a side effect. The burden is on the interventionist to show that the benefits outweigh the risks of the intervention.
What is the benefit of an in person visit and how will this help with drug diversion? In an era of technology, with the fanciest of diagnostic modalities and blood tests, the physical examination can be helpful for academic teaching and understanding, but it is marginally beneficial in addition to actually spending time talking to the patient and then adding all the high tech stuff. Sure, a neurologist (Dr. Brain) can spend 30 minutes doing a neurological exam to pinpoint an area affected by stroke, but the MRI would be way more accurate. Hematologists (Drs. Blood) and nephrologists (Drs. Kidney) make most of their decisions by talking to the patient and looking at lab tests. If the utility of being there in person is not in the diagnosis and management, then is it to vet the legitimacy of the patient to whom the controlled substance is going? Hmm, even without a high definition webcam, a doctor can see a patient through video, match the patient to their ID if they so choose, match the ID, name, and demographics to the pharmacy database, and the prescription is sent electronically to the pharmacy, which does the same ID matching as well. If the patient can fake all of that, how is seeing the patient in person going to change whether the drug is diverted? My guess is it’s not, but it will certainly make it harder for everyone to get that controlled substance prescription.
Some other interesting tidbits from this proposal:
Those who were started on a controlled substance during the relaxation of the telemedicine prescribing laws during the Public Health Emergency will not be grandfathered in. These patients will have a short grace period of 180 days to see Dr. In-the-Flesh.
If state laws conflict with federal, the stricter law supersedes. This will create a lot of confusion and inconsistency. For example, under this law, you could prescribe pregabalin (Schedule V) in Ohio and Michigan for more than 30 days after referral from Dr. In-the-Flesh, but not in Florida, as controlled substances cannot be prescribed through telemedicine there. If you wanted to prescribe hydrocodone (Schedule II), you could do this in Michigan but not Ohio or Florida, because Ohio does not allow Schedule II drugs through telemedicine (2).
This proposal does not include the allowance of a much-anticipated special telemedicine registration to allow certain providers to prescribe controlled substances via telemedicine without an in-person exam with an additional qualifying process. The DEA has determined the special registration to be “potentially burdensome for both prospective telemedicine providers and patients.” WHAT?! This entire proposal is already burdensome to doctors and patients, and you are saying the exemption is too burdensome?! I know the DEA is non-political but this is among the best political spin wording I have encountered.
Among other numerous administrative burdens, the DEA will require the writing of “telemedicine prescription” on the electronic prescription order, potentially leading to bias against the prescription, giving pharmacies yet another reason not to fill the legitimate prescription, which is already occurring to some extent. This will lead to further delays and barriers to patients getting their treatment.
Let’s turn the focus to how this may impact my own field of sleep medicine. There is almost no role for an in-person examination in sleep medicine. Nearly all medications in sleep medicine are controlled substances. Thus, the DEA is saying that nearly all of these patients that do not need to be seen in person for medical reasons, must now be seen in person to get the treatments. Common sleep conditions like sleep apnea, insomnia, restless legs syndrome (RLS), sleepwalking, circadian rhythm disorders, and even rare conditions like narcolepsy type 1 do not have in-person physical examination findings as part of their diagnosis and management. Chronic insomnia is treated with cognitive and behavioral therapy (CBT-I) as first-line, which can be done through telemedicine or even an app. However, nearly all second-line treatments are controlled substances such as your famous hypnotics like zolpidem (Ambien®) and eszopiclone (Lunesta®) and those old sedative-hypnotics like lorazepam (Ativan®), all of which are Schedule IV. After iron supplementation and infusion, alpha-2-delta ligand medications–gabapentin, gabapentin enacarbil (Horizant®), and pregabalin are first-line (Schedule V) (3). Opioids (Schedule II/III) are second-line for moderate to severe RLS (4). If you have shift-work disorder and behavioral interventions fail, the first-line is Schedule IV modafinil (Provigil®) or armodafinil (Nuvigil®). If you have Parkinson disease with REM sleep behavior disorder, melatonin may work, but you may need clonazepam (Klonopin®), which is Schedule IV. Almost all drugs for narcolepsy type 1 are Scheduled too. I could keep going but you get the point when it comes to sleep medicine.
And of course, this can be applied to many other fields of medicine. You have a chronic bowel problem and see a GI doctor via telemedicine for diarrhea: Oops! Lomotil® (diphenoxylate/atropine) is Schedule V. You and your diarrhea better head over to the GI doctor before 30 days or your prescription will run out (5). Do you have low testosterone and see an upstate endocrinologist via telemedicine? Well, that testosterone (Schedule III) will end if you don't get over in person to your PCP to get that referral from Dr. In-the-Flesh. What if it takes six weeks to see Dr. In-the-Flesh in person?
OK, I have made my point. As a telemedicine physician who prescribes only controlled substances, I am no doubt biased. The Docket No. DEA–407 in my biased view is highly regressive, and I am unable to see how these onerous barriers to prescribing controlled substances by licensed medical professionals will even marginally improve the Opioid Epidemic ravaging this country. If it does, it certainly will do so at great cost to those with legitimate conditions needing these valuable treatments.
But that’s not the end of this blog. If you’ve come this far, I did mention that this is a proposal. Yes, if you are reading this before March 31, 2023, you still have time to submit public comments about this. I have done this. I recommend you do as well, whether you are a physician who will now spend even more time chasing referrals from Dr. In-the-Flesh, or a patient in the Florida Keys who must drive 8 hours to see the right Dr. In-the-Flesh in person. Please tell the DEA what you think, maybe even in person.
-Andy Berkowski, MD of ReLACS Health, working 100% telemedicine all the time, regardless of the outcome of Docket No. DEA–407
P.S. Given my lack of understanding of DEA-speak, if there are any little factual errors or misinterpretations of the Docket, drop me a comment.
Footnotes (an idea from reading this piece by the late David Foster Wallace, except I don’t know how to code, so I can’t really do footnotes on a website yet, but this should suffice):
Jokes aside, I do not advocate giving any prescription drug that was prescribed to you to anyone else. The reason they require prescription is that they have potential harm and should be managed by a licensed healthcare provider with sufficient knowledge of the effect on the individual taking the drug. Even non-prescription drugs like acetaminophen (Tylenol®) could kill you.
I doubt states will ever agree to the same controlled substance policy. However, most seem to agree on the current Daylight Saving Time disaster for some reason…
To illustrate how different prescribing laws are in each state, gabapentin is Schedule V in Michigan, a monitored but not controlled drug in Ohio, and neither monitored or controlled in several other states.
As a reminder, dopamine agonists should NOT be used for RLS with rare exception. However, dopamine agonists, despite causing drug dependence, are not Scheduled medications, so this difference may influence providers to use them more to avoid the hassle of controlled substance prescribing.
I had to restrain myself from adding a pun in poor taste here but some of you wiseacres can probably imagine versions of what I would have said!
