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DEA to Give Docs a Telemedicine Outlet for Prescribing Controlled Drugs

Analysis  |  By Eric Wicklund  
   January 16, 2025

The long-awaited proposal for a special registration would help providers with virtual treatment programs for addiction and behavioral health concerns. Critics, however, say the proposed rule isn't what they hoped it would be.

Healthcare providers will finally get a special registration to dispense controlled drugs via telemedicine, a kay part of virtual care treatment for patients in substance abuse and behavioral health treatment.

But the proposed rule, unveiled Wednesday by the U.S. Drug Enforcement Administration (DEA) and expected to be published on Friday, isn’t necessarily sitting well with telehealth advocates.

The proposed rule creates three tiers of providers who could prescribe controlled drugs. The first tier comprises clinicians wanting to prescribe Schedule III-V level drugs; the second would apply to specialists, such as pediatricians, psychiatrists and those in hospice or palliative care, who want to prescribe Schedule II drugs. The third tier would comprise clinicians wishing to prescribe Schedule II-V medications via telemedicine and would require that they register with the DEA through Form 224S.

“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,” the DEA noted. “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.”

Among the restrictions included in the proposed policy: Providers wishing to prescribe controlled medications via telemedicine must be located physically in the same state as their patients, and they must issue at least half of their prescriptions after in-person appointments.

In addition, providers seeking a special registration to virtually prescribe controlled substances must check prescription drug monitoring databases in all 50 states and U.S. territories (the one exception is buprenorphine, or Suboxone, for which providers would only have to check the database in the state where the patient is located). That provision would take effect three years after the proposed rule becomes law.

[Also read: DEA Extends Telemedicine Prescription Waiver One More Year.]

The DEA announcement comes after the agency extended a pandemic-era waiver three times that allowed providers to prescribe via telemedicine, and comes 17 years after the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 mandated that the agency create a special registration process.

Telehealth advocates, led by the American Telemedicine Association, and several lawmakers have criticized the DEA’s efforts for years, first for ignoring the mandate to create a special registration, then for proposing mandates that they say are restrictive or convoluted.

“It is clear that these updates carry significant implications for the telehealth community,” Kyle Zebley, the ATA’s senior vice president of public policy and executive director of the organization’s lobbying arm, ATA Action, said in a press release. “Early indications suggest the proposed rule includes elements that represent significant operational challenges. 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.”

“We are pleased to see the DEA propose a special registration, as required by statute, to allow comprehensive medical care through telemedicine, including Schedule II medications,” the Alliance for Connected Care said in a release issued shortly after the DEA’s notice of proposed rulemaking. “These treatments are important in providing mental health, end-of-life care, substance use treatment, and many other services. Telemedicine has proven to be an effective tool in bridging the gap between patients and providers, reducing barriers to care, and supporting those most in need.”

“However, the alliance is very concerned to see language in the proposed rulemaking mandating what portion of patient care can be offered through telemedicine, as this is not an appropriate guardrail for a telehealth service,” the organization continued. “Similarly, restricting the geography in which telemedicine can be offered undermines the value of creating virtual access for those patients who need it most. Restricting access to telemedicine will lead to harsh consequences for many Americans relying on telehealth for mental health, substance use disorder, sleep disorders, terminal illness, and many other medical issues.”

The Foley & Lardner law firm, whose Telemedicine & Digital Health Industry team has long monitored the quest for a special registration, also panned the new proposal.

“The DEA published these rules, not because they were fully ready for implementation, but to ensure they were not abandoned by the incoming Trump administration,” Marika Miller, a telehealth and regulatory attorney with the firm, told STAT News. “The long-awaited special registration process falls flat with stakeholders, and it is anticipated that the associated rule will undergo yet another round of notice-and-comment rulemaking. Among other concerns, a key issue for stakeholders with both rules is the nationwide prescription drug monitoring program check requirement, a burden the DEA still appears to underestimate.”

The proposed rule, which will now face public comments through March 15, isn’t guaranteed. The incoming Trump Administration, which hasn’t yet named someone to lead the DEA, could drop or ignore the rule, reinstating the policy in place prior to the COVID-19 pandemic.

Eric Wicklund is the associate content manager and senior editor for Innovation at HealthLeaders.


KEY TAKEAWAYS

Since 2008, providers have been mandated to prescribe controlled medications in person, with some leeway to use telemedicine after an initial in-person visit.

Controlled medications like buprenorphine are critical in the treatment of patients with substance abuse and some behavioral health concerns, and providers say a virtual platform can expand treatment and reach more patients.

Federal officials have long defied a mandate to create a special registration, hinting that telemedicine would be an easier platform for fraud and misuse.


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