The U.S. Drug Enforcement Agency’s proposed rule to establish special registrations for providers and telemedicine platforms to prescribe certain schedules of controlled substances without requiring an in-person doctor’s visit requires “meaningful” clarification and adjustments, according to the American Telemedicine Association and ATA Action.
If key provisions to ensure “workability and effectiveness” are not addressed, “significant gaps will remain, leaving too many patients without access to necessary care,” ATA said in the February 14 comment letter signed by Kyle Zebley, ATA senior vice president of public policy and executive director of ATA Action.
WHY IT MATTERS
ATA Action emphasized the need for the DEA to balance expanded patient access via virtual care with necessary safeguards against prescription misuse in its letter to Derek Maltz, the acting DEA Administrator.
“Many aspects of the rule are workable for the telehealth community,” Zebley stated, but without changes, the provisions will create “unnecessary barriers to care.”
Zebley outlined nine areas of concern, leading with clinical, operational and technical issues with eligibility requirements.
“First, the proposed requirement mandates special registrant prescriptions for Schedule II controlled substances average less than [50%] of the special registrant’s prescriptions per month,” he said.
“This requirement does not account for unique needs of specialized providers such as psychiatrists and pain management specialists, both of whom routinely prescribe Schedule II substances within the course of their practice. This requirement could arbitrarily prevent qualified practitioners from effectively serving patients via telemedicine.”
These include primary care and general practitioners who increasingly integrate behavioral health into their practices to improve access.
Zebley also asked for clarification on 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 continuity of care for adults, adolescents and children.”
The telehealth organization asked the agency to better explain its authority to impose a registration framework for telemedicine platforms under the Controlled Substances Act and if the agency has the capacity to efficiently process and approve high volumes of applications without delay.
In the interest of minimizing administrative burdens, ATA Action urged the DEA to streamline the verification process by considering a single, universal DEA number per provider and asked for clarifications on patient identity photo verification requirements and “whether verifying all five DEA numbers on each prescription is considered part of pharmacists’ corresponding responsibility.”
ATA Action also sent a separate letter to Maltz in response to the Final Rule Expansion of Buprenorphine Treatment via Telemedicine, commending the increase in the initial prescription supply limitation via audio-only telemedicine encounters from 30 days to a six-calendar month supply. The inability to prescribe buprenorphine via telehealth for substance abuse disorder has been a concern since before the end of the COVID-19 public health emergency.
THE LARGER TREND
After DEA released its plan to create a special telehealth registration for prescribers last month, ATA quickly flagged that certain proposed provisions outlined in the notice of proposed rulemaking for the new telehealth controlled substance registry framework would create significant operational challenges for providers.
“It is clear that these updates carry significant implications for the telehealth community,” Zebley, had said after the NOPR was released in the Federal Register.
A week later, DEA announced it would exempt Veterans Affairs’ virtual care providers from participating in a federal telehealth controlled substance registry framework if the patient had a previous in-person visit.
ON THE RECORD
“The proposed rule authorizes qualified, specialized practitioners to prescribe Schedule II-V controlled substances through telemedicine by creating two distinct prescriber registration frameworks,” Zebley said in the organization’s comments. “However, the proposal introduces several restrictive measures on prescribing Schedule II-V controlled substances that, while well-intended, may restrict access to care or interfere with ongoing treatment of many individuals.”
Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.