Telemedicine Prescribing Waivers Extended
On May 10, 2023, the Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) announced they are extending the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications waiver for an additional six months (through November 11, 2023). These flexibilities have been in place since March 16, 2020, when the DEA and Department of Human and Health Services (HHS) declared the COVID-19 pandemic to qualify as an exemption to the Ryan Haight Act (aka the Ryan Haight Online Pharmacy Consumer Protection Act of 2008). Additionally, they added a one-year grace period (from November 11, 2023, to November 11, 2024) for any practitioner-patient relationship established during the waiver period.
This extension is a positive development for both patients and healthcare providers alike. Telemedicine can improve patient care outcomes, make accessing care easier, and reduce costs (time and travel-related expenses). Moreover, it demonstrates a significant change in position from the DEA’s proposed post-pandemic rules released on February 24, 2023.
Those proposed rules received a record 38,369 comments (mostly concerns and criticism) in the public open comment period. There were several themes in the comments: MAT (medication assisted treatment) for opioid use disorders, hormone-related treatment, ketamine treatment, rural access to care, encouragement to enact the Special Telemedicine Registration Process, and treatment for ADHD, among others.
The DEA’s initial proposed rules singled out ADHD (Thank you Done & Cerebral).
I’ll specifically discuss the proposed rules and how they would have impacted ADHD treatment. The DEA Controlled Substances Schedule is also included below for easy reference. The February 24 proposed rules essentially would have allowed for a single prescription of a non-narcotic Schedule III, IV, or V controlled substance (or buprenorphine for treating opioid use disorder) to be issued after a telemedicine-only examination. Said differently, the proposal would have allowed for any medication to be prescribed without an in-person visit except for opiates (makes sense), barbiturates (makes sense), and stimulant medications (doesn’t make sense).
Opiates are primarily prescribed to treat pain. Before prescribing such medication, a physical exam or medical imaging (i.e., an x-ray, CT scan, or MRI) would be warranted.
Barbiturates are primarily utilized to induce anesthesia, treat refractory seizures, or rarely as a treatment for migraines. Similar to opiates, a physical exam and/or medical imaging would be warranted. These medications are also not prescribed very often these days.
Stimulant medications are first-line treatments for ADHD treatment. There is no physical examination required. When was the last time your psychiatrist performed a physical exam? The diagnosis of ADHD can be made via clinical examination, neuropsychological testing, and/or a CPT (Continuous Performance Test such as TOVA, QBTest, IVA, etc.). There is no specific blood test or medical imaging that would diagnose ADHD.
Understandably, the DEA wants to ensure these medications are being prescribed appropriately. What’s incomprehensible is how slow the DEA has been to act in investigating companies such as Done, Cerebral, and other online startups that have made a mockery of prescribing these medications.
So now what?
The DEA and SAMHSA have commented they are still reviewing the record number of comments they have received. They will need to take those comments into consideration before publishing the final post-pandemic rules. Ideally, the proposed rules are released by no later than August 31st, with a similar month-long open comment period. This would allow Americans and various healthcare organizations to voice their support or concerns while also allowing them time (if needed) to prepare ahead of November 11th, 2023.
Definition of Controlled Substance Schedules
Drugs and other substances that are considered controlled substances under the Controlled Substances Act (CSA) are divided into five schedules. An updated and complete list of the schedules is published annually in Title 21 Code of Federal Regulations (C.F.R.) §§1308.11 through 1308.15. Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused. Some examples of the drugs in each schedule are listed below.
Schedule I Controlled Substances
Substances in this schedule have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.
Some examples of substances listed in Schedule I are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine (“Ecstasy”).
Schedule II/IIN Controlled Substances (2/2N)
Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence.
Examples of Schedule II narcotics include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®), oxycodone (OxyContin®, Percocet®), and fentanyl (Sublimaze®, Duragesic®). Other Schedule II narcotics include: morphine, opium, codeine, and hydrocodone.
Examples of Schedule IIN stimulants include: amphetamine (Dexedrine®, Adderall®), methamphetamine (Desoxyn®), and methylphenidate (Ritalin®).
Other Schedule II substances include: amobarbital, glutethimide, and pentobarbital.
Schedule III/IIIN Controlled Substances (3/3N)
Substances in this schedule have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.
Examples of Schedule III narcotics include: products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with Codeine®), and buprenorphine (Suboxone®).
Examples of Schedule IIIN non-narcotics include: benzphetamine (Didrex®), phendimetrazine, ketamine, and anabolic steroids such as Depo®-Testosterone.
Schedule IV Controlled Substances
Substances in this schedule have a low potential for abuse relative to substances in Schedule III.
Examples of Schedule IV substances include: alprazolam (Xanax®), carisoprodol (Soma®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), and triazolam (Halcion®).
Schedule V Controlled Substances
Substances in this schedule have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.
Examples of Schedule V substances include: cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®, Phenergan with Codeine®), and ezogabine.