Telehealth Controlled Substances: Evidence Mounts Against DEA Restrictions

With the COVID public health emergency (PHE) scheduled to end on May 11, 2023, the issue of prescribing controlled substances via telemedicine and telehealth has taken center stage. Before COVID, prescribing controlled substances was prohibited without in-person assessments, and practitioners had to obtain a special registration from the DEA for telehealth controlled substances. These requirements have been fiercely debated since the Department of Drug Enforcement (DEA) enforcement of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. The initial ruling was put in place to protect consumers against unscrupulous Internet-based sales of prescriptions, which has continued in other forms. However, in light of the recent events detailed below, the telehealth community of prescribers will likely prevail against their position that in-person assessments should be optional when prescribing controlled substances via telemedicine, telehealth, or any Internet-mediated technology.

During the PHE, the following two pivotal changes were made to rules about telehealth controlled substances:

• Authorized practitioners could prescribe a controlled substance to a patient using telemedicine, even if the patient wasn’t at a hospital or clinic registered with the DEA. 
• Qualifying practitioners could prescribe buprenorphine to new and existing patients with opioid use disorder based on a telephone evaluation.

Current Research into Rationales for Prescribing Controlled Substances via Telemedicine

Led by researchers from the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), a recent study published in JAMA Network Open helps to shed needed light on the alleged dangers of prescribing controlled substances via telemedicine and telehealth. The landmark study involved the following:

• Looking at the number of overdose deaths involving buprenorphine between July 2019 and June 2021, the cross-sectional study included an overall sample size of 74,474 opioid-involved overdose cases.
• Data was pulled from the State Unintentional Drug Overdose Reporting System (SUDORS) to consider monthly buprenorphine opioid-involved deaths from 46 states and the District of Columbia.
• The involvement of other drugs was closely examined to see if deaths resulted from prescriptions by classifying deaths into the following non-mutually exclusive groups: “any other drug, any other opioid, IMFs (includes fentanyl and fentanyl analogs classified using toxicological, scene, and witness evidence), cocaine, methamphetamine, prescription stimulants, benzodiazepines, antidepressants, anticonvulsants, cannabis, and alcohol.”
• Death certificates were supplemented by information from the medical examiner or coroner reports to account for “sex, age, race and ethnicity, education, and county of residence of decedents.”

Landmark Telehealth Controlled Substances Study Conclusions

The widescale study found that the proportion of buprenorphine-related deaths did not increase compared to pre-COVID protocols of prescribing buprenorphine in person. The study reported that opioid-related deaths accounted for just 2.2% of all drug overdose deaths and 2.6% of opioid-involved overdose deaths. Summarizing their findings, the researchers stated,

Importantly, the proportion of buprenorphine-involved overdose deaths fluctuated but did not increase during the 15 months from April 2020 to June 2021 when buprenorphine prescribing regulations were relaxed due to the COVID-19 pandemic. These findings have important policy implications when policy makers consider whether COVID-19–related buprenorphine prescribing flexibilities should be permanently adopted.

The researchers also comment that their findings are consistent with previous publications that found little evidence to support the DEA pre-prohibitions against telehealth controlled substance prescribing without previous limitations.¹

Quoted in a press release published by the National Institute of Drug Abuse, Lauren Tanz, Sc.D., an epidemiologist at CDC’s National Center for Injury Prevention and Control and lead author on the study, stated,

These findings help us better understand the circumstances of overdose deaths involving buprenorphine, which is crucial in our ability to inform policy, ensure safety, and improve clinical outcomes for people with substance use disorders,” said Lauren Tanz, Sc.D., an epidemiologist at CDC’s National Center for Injury Prevention and Control and lead author on the study. “It is important to note the presence of other drugs in overdose deaths involving buprenorphine. The complex nature of substance use disorders and polysubstance use requires specific strategies to address it.

Additional Support

The Substance Abuse and Mental Health Services Administration (SAMHSA) has proposed a rule that would permanently allow providers to prescribe buprenorphine expressly for opioid use disorder treatment without an in-person visit to an opioid treatment program, but this is still in the proposal phase. Comments on the SAMHSA telehealth controlled substance proposal were closed on February 14, 2023. 

Also, the Department of Health and Human Services (DHHS) recently proposed a new rule to remove the requirement that practitioners obtain a waiver commonly known as the “X waiver” to prescribe certain III-V medications for treating opioid use disorder. Comments on the DHHS rule are due March 14, 2023. 

The White House Office on National Drug Policy (ONDCP) issued guidance in June 2022, acknowledging that access to telehealth controlled substances is essential to ensure that people with SUD continue to access care.

Check back in with Telehealth.org for updates as they emerge.

_{¹ Jones CM, Compton WM, Han B, Baldwin G, Volkow ND. Methadone-involved overdose deaths in the US before and after federal policy changes expanding take-home methadone doses from opioid treatment programs. JAMA Psychiatry. 2022;79(9):932-934. doi:10.1001/jamapsychiatry.2022.1776}

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