The U.S. Drug Enforcement Agency recently unveiled its proposed rulemaking for a framework that would allow for the prescription of medically necessary controlled substances via telemedicine without requiring an in-person visit, all while staying compliant with the Ryan Haight Online Pharmacy Consumer Protection Act.
Why is this significant?
This move comes on the heels of the DEA and U.S. Health and Human Services extending the pandemic-era flexibilities for virtual prescribing of controlled substances for the third time. This extension will remain in effect until 2025, ensuring continued access to telehealth-prescribed medications for patients.
The DEA’s proposed framework includes three types of special registration:
1. Telemedicine Prescribing Registration – for qualified clinician practitioners to prescribe Schedule III-V controlled substances.
2. Advanced Telemedicine Prescribing Registration – for specialized clinician practitioners to prescribe Schedule II-V controlled substances.
3. Telemedicine Platform Registration – for covered online telemedicine platforms to dispense Schedule II-V controlled substances.
By establishing this regulatory scheme, the DEA aims to balance patient access to care with measures to prevent and detect the diversion of controlled substances.
Industry response and concerns
The American Telemedicine Association has called on the DEA to create a workgroup to develop a permanent framework for remote prescribing of controlled substances. While the DEA has been diligent in its efforts, there are concerns about potential operational challenges and implications for the telehealth community.
The Alliance for Connected Care has expressed concerns about language in the proposed rulemaking that dictates the portion of patient care that can be provided through telemedicine. Limiting the proportion of Schedule II prescriptions issued via telemedicine could impact access for patients who rely on virtual care.
Looking ahead
The DEA is accepting comments on the proposed telehealth prescribing registry framework until March 15. Without further extensions, the expiration of telehealth prescribing flexibilities would require patients to have an in-person visit within 30 days to maintain access to medications.
Lawmakers and industry groups have emphasized the importance of maintaining telehealth prescribing flexibilities to prevent barriers to care for patients. The DEA’s efforts align with the Substance Use-Disorder Prevention and Treatment for Patients Act, aiming to provide telehealth access for needed medications while ensuring patient safety and preventing medication diversion.
