DEA Proposes Rules to Limit Telehealth Prescribing of Certain Controlled Medications 2023

The US Drug Enforcement Administration (DEA) proposed changes in late February 2023 to the pandemic-era tele-prescribing regulations, extending some regulations and curtailing others. DEA developed the draft rules with support from the US Department of Veterans Affairs (VA) and the US Department of Health and Human Services (HHS). Below is a look at what changes may be made if the rules are approved (public comment is open until March 31, 2023) and the impact on pain management, addiction treatment, and prescribers.

Narcotics and Stimulants

The new rules would end pandemic-era telemedicine exceptions, which currently allow authorized medical professionals to prescribe Schedule II narcotics and stimulants (ie, fentanyl, methadone, oxycodone, dextroamphetamine, methylphenidate, methamphetamine) via telehealth without an initial in-person evaluation. The federal COVID-19 based Public Health Emergency (PHE) period, which began March 31, 2020, is set to expire May 11, 2023. After this time, clinicians must see patients in person first before prescribing Schedule II medications via telehealth.

The proposed guidelines are based on the DEA Controlled Substances Act (CSA),¹ and the Ryan Haight Online Pharmacy Consumer Protection Act (RHOPCPA) of 2008²
for telehealth prescribing of controlled substances.

Non-Narcotics

The proposed new regulations do not affect tele-prescribing of non-narcotic medications, which can continue without the in-person visit requirement. Non-narcotic controlled substances that fall under Schedule III-V may also continue to be tele-prescribed for a maximum 30-day supply, with an in-person visit requirement for refills.

Medical providers would still be able to prescribe buprenorphine for opioid use disorder (OUD) for an initial 30-day supply via telemedicine without first conducting in-person patient consultation. This rule is in line with DEA’s goal of expanding access to OUD medication to anyone in the country who needs it. However, after the initial tele-prescription, patients would need to be seen in-person for an assessment in order to receive subsequent buprenorphine prescriptions.

In-Person Evaluations

Under the proposal, prescribers must first establish an in-person patient evaluation with new patients before they can prescribe any Schedule II medications, such as opioids, via telemedicine.

Providers who have prescribed and/or renewed Schedule II drugs via telehealth to patients who never had an in-person evaluation due to the COVID-19 emergency period will no longer be able to refill those prescriptions without first conducting an in-person patient evaluation. However, clinicians can continue to prescribe Schedule II medications via telemedicine to patients with whom they have conducted an in-person evaluation in the past in accordance with state and federal guidelines.³

The draft DEA rules also state:³⁻⁵

• A provider must be eligible to prescribe controlled substances in the state in which they practice and the state in which the patient resides (if different).
• The prescription must be issued for a “legitimate medical purpose” in the usual course of a practitioner’s professional practice according to state and federal laws.
• The prescription must note that it is based on a telehealth visit. It must contain the date, name, and address of the patient. It must contain complete information about the medication, dosage, and strength along with the practitioner address and the city and state of the patient at the time of the tele-medicine visit.
• Prescribers must review the state prescription drug monitoring program database (PDMP) prior to prescribing. If it’s unavailable, they must limit the tele-prescription to a 7-day supply until the PDMP data can be reviewed. All attempts to review PDMP data must be recorded.
• Prescribers must maintain detailed logs of all telemedicine-based prescriptions.

Prescribers can also tele-prescribe a controlled substance, including Schedule II narcotics, based on written telemedicine referrals from another DEA-authorized provider acting in the usual course of practice who has conducted an in-person evaluation of the patient. The referral must contain the provider’s name and their national provider identifier (NPI) number.

If the proposed guidelines are approved, medical practitioners, patients, and even telehealth companies that offer direct-to-patient telemedicine services will be affected –­ and not necessarily in positive ways.

Addiction Treatment

For instance, studies indicate that telehealth services have improved addiction treatment access and outcomes.⁶ More patients are staying in treatment with fewer overdose incidents. Some clinicians and patients have raised concerns in public comments to DEA regarding tele-prescribing restrictions for buprenorphine for OUD specifically. Since the new guidelines will require an in-person patient visit after an initial 30-day supply of buprenorphine via telemedicine, there is concern about treatment interruptions or increasing barriers to treatment access and the impact to patients in recovery.

For patients, reinstatement of in-person visit requirements for controlled substance prescriptions will mean they must travel at least once for an in-person assessment before they can get a narcotic prescription for an opioid, or stimulant medication for ADHD, for instance. This may present barriers for patients with transportation challenges, for those with disabilities, or for those with limited geographic healthcare access.

Jeff Gudin, MD, attending anesthesiologist at the University of Miami Miller School of Medicine and PPM’s Editor at Large, said, “During the acute phase of the COVID-19 pandemic, it was clinically reasonable to accept the increased risk of prescribing controlled substances virtually without an in-person examination. While prescribing via telemedicine, clinicians are unable to perform an adequate physical examination and often overlook necessary risk-mitigation tools including urine drug screening.”

He continued, “The pandemic did not change access for those with disparities in healthcare access – this still remains a prescribing challenge for clinicians.”

Additional Paperwork

Prescribers will have additional record-keeping burdens for tele-prescribing. In addition, practitioners who were able to prescribe Schedule II medications without geographic state limits via telehealth may need to have multiple state licenses when tele-prescribing in some cases (they must be licensed in the state they practice and the state in which the patient lives). In addition, practitioners will need to meet various tele-prescribing regulations for different scheduled medications (II-V) and to make telehealth patient referrals.

Telehealth-Only Providers

Telehealth companies that have focused primarily on chronic pain management or ADHD for their tele-prescribing business will face challenges with the new tele-prescribing guidelines. These companies may be constrained based on the new proposed guideline requirements for in-person patient evaluations. The rapid growth of new telemedicine companies during the pandemic has also led to questions about the quality of care offered and raised patient safety concerns. DEA has issued warnings to some telehealth companies regarding their tele-prescribing practices of Schedule II prescriptions that may be in violation of federal laws.

According to Nidal Moukaddam MD, PhD, associate professor in psychiatry and behavioral sciences at Baylor College of Medicine, Houston, Texas, “The new guidelines will certainly create some access and convenience challenges for patients, however, at the same time, they will also ensure clinicians have the opportunity to conduct more thorough evaluations in-person for complex behavioral health disorders such as substance use disorder or ADHD.”

Dr. Moukaddam continued, “Tele-prescribing will not solve the myriad personal, societal, and systemic aspects affecting patient care today including provider shortages.” She explained, “Patients need to be assessed in person from time to time to provide the clinician with a better understanding of their clinical progress, which is not always possible with a telehealth visit.”

Dr. Gudin added, “Clinicians can help patients navigate these proposed changes by setting office policies, communicating those policies via email/website and other means, and mandating regular office visits. For those with significant mobility disabilities, clinicians should check their state medical board policies for recommendations as to the recommended maximum length of time between office visits when prescribing controlled substances.”

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