The U.S. Drug Enforcement Agency has released its notice of proposed rulemaking for a framework to permit medically necessary controlled substances without an in-person visit without violating the Ryan Haight Online Pharmacy Consumer Protection Act.
WHY IT MATTERS
The NPRM comes two months after the DEA and U.S. Health and Human Services announced they extended the pandemic-era virtual prescribing of controlled substances a third time. The most recent extension of COVID-19 flexibilities for prescribing runs through 2025.
DEA’s Goal
"DEA has determined that the best course of action to ensure patient access to care, while maintaining sufficient safeguards to prevent and detect diversion of controlled substances, is to establish and maintain a regulatory scheme," the agency said in the notice published Wednesday.
Telemedicine Prescribing Registration
To prevent patients from losing access to their telehealth-prescribed medications, the DEA is offering three types of special registration:
- Telemedicine Prescribing Registration – authorizes qualified clinician practitioners to prescribe Schedule III-V controlled substances.
- Advanced Telemedicine Prescribing Registration – authorizes qualified specialized clinician practitioners to prescribe Schedule II-V controlled substances.
- Telemedicine Platform Registration – authorizes qualified covered online telemedicine platforms – in their capacity as platform practitioners – to dispense Schedule II-V controlled substances.
Industry Reaction
Kyle Zebley, senior vice president of public policy for the American Telemedicine Association and executive director of ATA Action, said in a letter Tuesday, "While we are still digesting the DEA’s Special Registration framework, and will have a comprehensive analysis shortly, it is clear that these updates carry significant implications for the telehealth community."
Concerns and Criticism
The Alliance for Connected Care said in a statement that it is "very concerned to see language in the proposed rulemaking mandating what portion of patient care can be offered through telemedicine" and deemed it an inappropriate guardrail.
The Larger Trend
Without a third extension before the end of 2024, the expiration of telehealth prescribing flexibilities would have required patients to have an in-person visit with a provider within 30 days or lose access to medications.
Conclusion
The DEA’s proposed rulemaking aims to provide telehealth access for needed medications while ensuring patient safety and preventing the diversion of medications into the illicit drug market. The agency is accepting comments on the proposed telehealth prescribing registry framework through March 15.
Frequently Asked Questions
Q: What is the purpose of the proposed rulemaking?
A: The purpose is to establish a regulatory scheme to permit medically necessary controlled substances without an in-person visit without violating the Ryan Haight Online Pharmacy Consumer Protection Act.
Q: What are the three types of special registration offered by the DEA?
A: They are Telemedicine Prescribing Registration, Advanced Telemedicine Prescribing Registration, and Telemedicine Platform Registration.
Q: What is the deadline for commenting on the proposed telehealth prescribing registry framework?
A: The deadline is March 15.
Q: What is the goal of the DEA’s proposed rulemaking?
A: The goal is to provide telehealth access for needed medications while ensuring patient safety and preventing the diversion of medications into the illicit drug market.
