WASHINGTON—ATA Action, the advocacy arm of the American Telemedicine Association, submitted concerns and detailed recommendations on the Drug Enforcement Administration (DEA)’s proposed rule to establish special registrations for the remote prescribing of controlled substances without requiring an in-person visit.
ATA Action said while many aspects of the rule are workable for the telehealth community, without meaningful changes, significant gaps will remain, leaving too many patients without access to necessary care.
“ATA Action is a longtime advocate for a special registration process and recognizes the need to balance expanded patient access with necessary safeguards," said Kyle Zebley, senior vice president of public policy and the ATA and executive director of ATA Action. "However, key provisions in the draft rule require clarification and adjustments in order to create a practical and effective final rule that supports providers, enhances patient care and serves the broader public interest. We appreciate the agency’s thoughtfulness and efforts in drafting this proposed regulation and reinforce our commitment to collaborate with the DEA in good faith to refine the rule and ensure no patient is left behind.
“ATA Action believes clinical decision-making should be left to qualified medical professionals who can evaluate the appropriate level of care for each patient,” Zebley continued. “The role of the DEA should be to ensure patient safety and prevent misuse, not to dictate clinical decision-making for practitioners.”
In a letter to the DEA Acting Administrator Derek Maltz, ATA Action detailed the following concerns and recommendations:
Clinical, Operational & Technical Issues With Eligibility Requirements: ATA Action asks the DEA to disclose the methodology and data used to determine restrictive measures on prescribing controlled substances that could arbitrarily prevent qualified practitioners from effectively serving patients via telemedicine and disrupt the continuity of care for adults, adolescents and children.
Clarification on Telemedicine Platform Registration & Attestation Processes: ATA Action asks the DEA to explain its authority to impose a registration framework for telemedicine platforms under the Controlled Substances Act (CSA) and address unanswered logistical and compliance-related questions on the special registration for direct-to-consumer telemedicine platforms and attestation process requirement.
Unworkable Nationwide Prescription Drug Monitoring Program (PDMP) Check: ATA Action supports the idea of the PDMP check to safeguard against diversion and urges the DEA to retain language in the final rule that addresses technical and operational barriers in order to achieve the PDMP nationwide check.
Overly Burdensome Application, Cycles & Fees: ATA Action requests the DEA provide details and assurances that, in the event this proposed rule is finalized, the agency has the capacity to efficiently process and approve high volumes of applications without delay.
Potential Delays in Granting Special Registrations: ATA Action urges the DEA to extend existing flexibilities to allow for a gradual transition period to avoid months-long delays, leaving providers unable to prescribe controlled substances, and patients unable to receive the care they urgently need while the registration system is developed.
Increased Administrative Burden for Pharmacists, Delays for Patients from Additional DEA Verification Numbers: ATA Action urges the DEA to consider a single, universal DEA number per provider or implementation of an automated verification process that minimizes administrative burdens and maintains the integrity of controlled substances regulation.
Guidance on Geographic Red Flag Issue: ATA Action urges the DEA to issue clear guidance stating the prescriber’s physical location, in relation to the patient or pharmacy, should not be an automatic red flag, to clarify enforcement policies to reduce pharmacy uncertainty, and to collaborate with pharmacy organizations and state boards to align policies and prevent unnecessary prescription denials.
Clarify Patient Identity Verification: ATA Action asks the DEA to clarify the goal of this requirement so that telemedicine platforms and special registrants can determine the least burdensome way to comply.
Expansion of Buprenorphine Treatment via Telemedicine
ATA Action submitted a separate letter to DEA Acting Administrator Maltz in response to its Final Rule Expansion of Buprenorphine Treatment via Telemedicine, raising a few clarifying questions related to the Special Registrations for Telemedicine and Limited State Telemedicine Registrations, as well as the ongoing application of COVID-19 pandemic-era flexibilities.
“We appreciate the DEA’s revisions to the final rule regarding the expansion of buprenorphine treatment through telemedicine, including the increase in the initial prescription supply and the removal of the in-person evaluation requirement,” said Zebley. “However, it is crucial that the final special registration framework is designed appropriately—without unnecessary burdens, unclear requirements, or restrictive measures that could limit access to buprenorphine via telemedicine. We cannot afford to reverse the progress made by introducing new barriers to treatment, especially when continuity of care is more important than ever.
“On behalf of our members and the telehealth community, we urge the DEA to extend the pandemic-era flexibilities for remote prescribing of controlled substances or finalize a special registration rule that addresses the concerns outlined above before the end of the year," Zebley continued. "ATA Action, along with other concerned stakeholders, is ready to collaborate with the DEA to develop a safe, effective registration process that strikes the right balance between improving access to care, ensuring patient safety and preventing diversion."