The Drug Enforcement Administration (DEA) has finally announced the creation of a special registration process for prescribers looking to provide controlled substances through telemedicine, after a 16-year delay since the mandate was issued by Congress in 2008. This move comes with a set of restrictions that have sparked immediate criticism and pushback from various stakeholders.
One of the key restrictions is that providers wishing to prescribe Schedule II medications, such as Ritalin and Adderall, must be physically located in the same state as their patients. Additionally, they would be required to conduct at least 50% of their prescriptions after in-person appointments, which could pose a challenge for telehealth providers whose primary focus is on remote consultations.
The Alliance for Connected Care, a trade organization representing telehealth providers, expressed concerns about the proposed rule, stating that mandating the portion of patient care that can be offered through telemedicine is not an appropriate practice. They also criticized the geographical restrictions, arguing that it undermines the value of virtual access for patients in need.
The DEA’s new regulations come as a response to a law passed in 2008 regulating online pharmacies, which required the agency to establish a special registration process for practitioners prescribing controlled substances remotely. However, the process has faced significant resistance, particularly in relation to buprenorphine, a Schedule III medication used to treat opioid addiction.
In a separate rule, the DEA has allowed prescribers to continue providing six months’ worth of buprenorphine without requiring an in-person visit. This rule, set to take effect in mid-February, is in final form, making it more difficult for the Trump administration to reverse. Patients can renew their prescriptions either through an in-person visit or, if the broader telehealth proposal is finalized, receive a refill remotely from a specially registered prescriber.
Despite these efforts, pharmacies remain a challenge for patients seeking buprenorphine, as many do not stock the medication. The DEA’s rules also highlight distinctions between buprenorphine and other controlled substances, acknowledging the medication’s low risk of overdose.
Stakeholders have raised concerns about the nationwide prescription drug monitoring program check requirement, seen as an additional burden by many. The DEA’s future plans remain uncertain, with no nominee announced to lead the agency. The ongoing flexibility in telehealth prescribing provided during the Covid-19 pandemic faces potential challenges in finalizing regulations and ensuring continued access to medications prescribed via telemedicine.
It is essential to monitor the developments in DEA regulations and telemedicine practices to ensure patients’ access to necessary medications while maintaining safety and compliance with regulatory requirements.
