Should the DEA Allow Providers to Prescribe Controlled Substances via Telehealth Means?

The increase of telehealth flexibilities during the COVID-19 pandemic brought the efficacy of mental health and opioid use disorder treatments via telehealth to the forefront of the behavioral health conversation. Different approaches to telehealth-based behavioral health have reached a crescendo as the U.S. Drug Enforcement Agency (DEA) endeavors to promulgate legislation regarding online prescribing of controlled substances in the post-COVID-19 landscape.

In 2008, the DEA passed the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (RHA), an amendment to the Controlled Substances Act (CSA), which established an in-person medical evaluation requirement between a patient and a practitioner prior to prescribing a controlled substance. Under the RHA, the prescription of any controlled substance is the trigger for the in-person medical exam requirement. Controlled substances are commonly prescribed in the behavioral health space, including stimulants for attention deficit disorders, buprenorphine for treatment of opioid addiction, and benzodiazepines for anxiety disorders.

Overall, the use of telehealth across the U.S. shot up 154% during the first few months of the COVID-19 pandemic, ushering in a new chapter in the RHA’s history. The DEA temporarily waived the requirement of an in-person medical examination prior to the prescription of a controlled substance, and waived state registration requirements for such prescriptions for the duration of the pandemic. No additional rules were put in place in the interim, resulting in the prescription of controlled substances across state lines and a patchwork of state laws governing online prescribing activities. However, those waivers were set to expire (and did) on May 11, 2023. While providers were anticipating reverting back to an in-person requirement, the DEA and Substance Abuse and Mental Health Services Administration (SAMHSA) issued a proposed rule in March of 2023 titled ‘Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation.’ The proposed rule would allow practitioners to prescribe an initial 30-day supply of a Schedule III, IV, and V non-narcotic medication or a 30-day supply of buprenorphine to treat an opioid use disorder, without an in-person examination or referral from a practitioner who conducted an in-person evaluation, if certain requirements are met. Most notably, that the provider be licensed to prescribe narcotics in both the state the provider is located and the state the patient is located.

The proposed rules would allow a practitioner to prescribe a non-narcotic controlled substance via telehealth to provide an initial 30-day supply. But, if a patient required a refill, their provider would have to either (i) conduct an in-person visit; (ii) hold a telehealth real-time video appointment while the patient is physically located in the same room as another DEA-registered practitioner; or (iii) receive a telehealth referral from a DEA-registered practitioner who has performed an in-person examination of the patient. If, however, the medication is a Schedule II or Schedule III-V narcotic drug (excluding buprenorphine for OUD treatment), the patient would have to receive an in-person exam.

In response to the proposed rule, 38,000 comments—the most ever received by a proposed federal regulation—captured a variety of competing interests within the behavioral telehealth world. Given the scope of the comments, the federal government further extended the COVID-19 telehealth flexibilities through December 31, 2024.

Many see the provision of behavioral health care via telehealth as essential to the mental health and opioid crises, while others consider telehealth as being far from best practice in diagnosing or treating certain behavioral health conditions. The issue presents a behavioral health conundrum. On one hand, most large metropolises and rural areas do not have enough behavioral health providers. Thus, some practitioners view telehealth as the key to maintaining access to necessary treatments and, in turn, the cornerstone to solving the mental health crisis. On the other hand, increasing access to controlled substances via telehealth raises concerns of fueling the opioid crisis. Thus, other practitioners cite telehealth flexibilities as detrimental to proper patient care.

While criticism and conversation addressed an almost infinite number of topics, a few common suggestions became apparent. Multiple behavioral health proponents suggested tightening enforcement on bad actors, urging the DEA to take an investigative approach in eliminating improper practices rather than promulgating a strict, blanket rule for all telehealth controlled substance prescribers. Another common suggestion was to develop a national prescription drug monitoring program, allowing practitioners to see the quantity, frequency and duration of certain prescriptions received by patients across state lines.

Ultimately, the future of the telehealth online prescribing landscape now lays with the DEA and SAMHSA. Importantly, these federal laws and rules set the floor. State laws may preempt federal laws, which adds another layer of considerations for telehealth-based practices reaching patients across state lines. Bradley is monitoring the updates from the DEA as it continues to release new guidance for practitioners and behavioral health practices. Please contact Evie Lalangas at elalangas@bradley.com or Elaine Moore at elmoore@bradley.com for more information.