WASHINGTON – The U.S. Drug Enforcement Administration is announcing three new rules to make permanent some temporary telemedicine flexibilities established during the COVID-19 public health emergency while also establishing new patient protections.
In developing these rules, DEA has focused on the patient to ensure telemedicine is accessible for medical care. Importantly, these rules do not apply to telemedicine visits in which a patient has already been seen in-person by a medical provider. Once a patient has had an in-person visit with a medical provider, the medical provider may prescribe any medications through telemedicine indefinitely. Also, if a telemedicine visit does not involve a patient being prescribed medications, then the telemedicine rules do not apply. Patients can always have telemedicine visits with medical providers. These rules only apply if a patient has never been seen in-person by the medical provider and the patient is being prescribed controlled medication.
“DEA’s goal is to provide telehealth access for needed medications while ensuring patient safety and preventing the diversion of medications into the illicit drug market,” said DEA Administrator Anne Milgram. “We understand the difficulties some patients have accessing medical providers in-person, and we want to ease this burden while also providing safeguards to keep patients safe. These rules also mark a significant step forward for patient safety by requiring online telemedicine platforms to register with DEA and taking steps to establish a nationwide Prescription Drug Monitoring Program (PDMP).”
Expansion of Buprenorphine Treatment via Telemedicine Encounter
This rule provides patients with remote access to buprenorphine, the medicine used to treat opioid use disorder. This change allows a patient to receive a 6-month supply of buprenorphine through a telephone consultation with a provider. Further prescriptions of buprenorphine will require an in-person visit to a medical provider.
Special Registrations for Telemedicine and Limited State Telemedicine Registrations
This proposed rule would establish special registrations that will permit a patient to receive prescribed medications through telemedicine visits without ever having an in-person medical evaluation from a medical provider. The special registration is available to medical providers who treat patients for whom they will prescribe Schedule III-V controlled substances. An Advanced Telemedicine Prescribing Registration is available for Schedule II medications when the medical practitioner is board certified in one of the following specialties: psychiatrists; hospice care physicians; physicians rendering treatment at long term care facilities, and pediatricians for the prescribing of medications identified as the most addictive and prone to diversion to the illegal drug market. This regulation allows specialized medical providers to issue telemedicine prescriptions for Schedule II-V medications.
DEA is seeking public comment on additional medical specialists that should be authorized to issue Schedule II medications. Public comments will also be requested on additional patient protections for the prescribing of Schedule II medications by telemedicine, including whether the special registrant should be physically located in the same state as the patient being prescribed schedule II medications; whether to limit schedule II medications by telemedicine to medical practitioners whose practice is limited to less than 50% of prescriptions by telemedicine; and the appropriate duration needed for the rules’ provisions to be enacted.
For the first time online platforms that facilitate connections between patients and medical providers that result in the prescription of medications will be required to register with DEA. This is critical as DEA has found some unscrupulous medical providers on online platforms have used flexible telemedicine rules to put profit ahead of the well-being of patients.
The special registration rule will also require the establishment of a national PDMP to help the health industry protect against abuse and the diversion of controlled substances into the illegal drug market. A national PDMP will provide pharmacists and medical practitioners with visibility of a patient’s prescribed medication history.
The new rules were developed in consultation with the U.S. Department of Health and Human Services and after significant input from the public. DEA received input during public listening sessions that were hosted by DEA in September 2023. Healthcare practitioners, experts, advocates, and patients shared their experiences and recommendations. DEA also carefully reviewed and considered the more than 38,000 comments from the public in response to the original draft rule that was proposed on March 1, 2023. As a result of the comments and listening session, DEA has now made significant revisions to the draft rules.
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