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UPDATED 1:40 p.m. ET
The Drug Enforcement Administration released a notice of proposed rulemaking that would create a three-tiered special registration system for the remote prescribing of controlled substances.
An unpublished version of the proposed rule (PDF) can be reviewed in the Federal Register. The proposed rule will publish January 17.
The agency most recently issued a blanket extension of the COVID-19-era flexibilities for one year, through Dec. 31, 2025 when it became clear there was significant industry opposition to an alleged DEA rule that was leaked to the press in August.
In this proposed rulemaking’s approach, DEA distinguishes telemedicine providers by architecting three distinct categories subject to different levels of scrutiny. The first special registration system would apply to mid-level practitioners seeking to prescribe Schedule III-V controlled substances via telehealth.
The second, or advanced special registration, would require heightened scrutiny for providers seeking to prescribe schedule II controlled substances, which are considered riskier and more susceptible to diversion. The advanced registration would only be available to providers in certain specialties, like psychiatry, hospice and palliative care, and pediatricians. Some mid-level practitioners may also be able to prescribe schedule II substances if they show proof of expertise or professional training.
DEA includes two additional requirements for schedule II substances. One is that the patient and provider must be located in the same state. Additionally, a provider with an advanced special registration could prescribe no more than half of Schedule II prescriptions via telehealth.
This “50%” restriction is consistent with the information that was leaked in August about a DEA proposed rule on this topic.
The third tier would register telemedicine platforms seeking to prescribe Schedule II-V controlled substances with the DEA. This is the first time the agency is proposing to regulate the slew of telehealth businesses that rose in popularity after the onset of the COVID-19 public health emergency.
The DEA acknowledges this departure in its proposed rule and says that the new post-pandemic norm of telemedicine requires a new regulatory approach by the agency. DEA clarifies that a telehealth platform “explicitly excludes certain types of entities, including hospitals, clinics, insurance providers, and local in-person medical practices.”
“The rise of DTC online telemedicine platforms in recent years has further transformed healthcare delivery, but it has also introduced new challenges and heightened risks of diversion due to the remote nature of care delivery,” DEA wrote in the proposed rule. “The proposed registration requirements for telemedicine-based prescribing and dispensing create a new business activity within DEA’s overarching registration framework, distinguishing it from the traditional modes of dispensing under a 21 U.S.C. 823(g) registration.”
DEA also says that telemedicine platforms could have “financial incentives tied to prescriptions and/or do not adequately screen the clinician practitioners utilizing their system or platform.” The agency cites concerns of patients “doctor shopping” on online platforms.
A new form, Form 224S, would be used to complete the registrations, which are proposed to run on a three-year cycle. On the form, telemedicine companies would be required to disclose "employment, contractual relationships, or professional affiliations with any clinician special registrant and Online Pharmacy and their respective registration numbers.”
For a telemedicine company to register to prescribe controlled substances in all 50 states, it could cost upwards of $40,000, according to the proposed rule. For individual clinicians registering in multiple states, DEA proposes an $888 registration fee and an additional fee of $50 per state.
The rule would require providers to be licensed by the DEA in each state where they prescribe. It would also mandate providers to check the state prescription drug monitoring program in the state where the patient is located, the state where the provider is located and any state with a reciprocity agreement to the patient’s and provider’s states.
After three years, providers would be required to check all 50 states’ PDMPs, if they are available. The DEA noted that currently it is not possible for a provider to check all other states’ PDMPs, but it said that it expects the interoperability of state registries to advance in the coming years.
A former DEA official said the rule is “very bad for industry as it will basically shut down telemedicine and put a lot of companies out of business,” in a statement to Fierce Healthcare.
The American Telemedicine Association released an initial reaction to the rule along the same lines. “Early indications suggest the proposed rule includes elements that represent significant operational challenges,” Kyle Zebley, senior vice president of public policy, said. “All stakeholders need time to carefully review this important proposal, which appears to incorporate valuable elements and other potentially unworkable restrictions that focus on maintaining compliance with patient verification, electronic recordkeeping, and ongoing monitoring.”