The Drug Enforcement Administration (DEA) recently announced making permanent changes to the rules for prescribing controlled medicines and buprenorphine via telemedicine. The proposed rules, developed with input from the Department of Health and Human Services (HHS) and the Department of Veterans Affairs (VA), aim to extend many of the flexibilities adopted during the COVID-19 public health emergency.
The proposed rules would provide safeguards for telemedicine consultations performed by a medical practitioner that has never seen the patient for an in-person consultation and that involves a controlled medication prescription. In those situations, the proposed rules would allow the practitioner to prescribe a 30-day supply of Schedule-III-V non-narcotic controlled medications or a 30-day supply of buprenorphine for the treatment of opioid use disorder without an in-person evaluation of the patient or referral from a practitioner that has conducted an in-person evaluation. Of course, the prescription must comply with any applicable federal or state laws.
After the 30-day prescription, the patient must see a medical practitioner in-person before a refill can be written. As long as the patient has seen either the prescriber or the referring provider in-person, all prescriptions can be prescribed via telehealth. Additionally, the patient’s in-person visit for a refill (or prescription of a greater than 30-day supply) can be with another practitioner while on an interactive video link with the prescribing practitioner.
Additionally, if a patient needs a Schedule II medication or narcotic, that prescription cannot be done solely via telemedicine and the patient must either see a medical practitioner in-person for the prescription or have previously seen the prescriber (or referring provider) in-person.
The proposed rules would not impact telemedicine consultations that do not involve prescribing of controlled medicines. The proposed rules would also not impact telemedicine consultations by a medical practitioner that has previously conducted an in-person medical exam on the patient or telemedicine consultations and prescriptions by a practitioner to whom a patient has been referred if the referring practitioner has conducted an in-person medical exam of the patient. In the second two situations, those practitioners can prescribe any medication, compliant with state and federal laws.
Additionally, if a provider-patient relationship was formed via telemedicine during the COVID-19 public health emergency, the proposed rules maintain the current health flexibilities for 180 days after the end of the emergency. To continue prescribing a controlled medication via telemedicine beyond 180 days from the end of the public health emergency, an in-person evaluation of the patient must be done. Prescriptions written via telemedicine during the 180 day extension will require additional recordkeeping obligations.
Prescriptions written by medical practitioners via telemedicine based on a referral relationship will also require additional recordkeeping obligations.
“DEA is committed to ensuring that all Americans can access needed medications,” said DEA Administrator Anne Milgram. “The permanent expansion of telemedicine flexibilities would continue greater access to care for patients across the country, while ensuring the safety of patients. DEA is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm.”
“Improved access to mental health and substance use disorder services through expanded telemedicine flexibilities will save lives,” said HHS Secretary Xavier Becerra. “We still have millions of Americans, particularly those living in rural communities, who face difficulties accessing a doctor or health care provider in-person. At HHS, we are committed to working with our federal partners and stakeholders to advance proven technologies and lifesaving care for the benefit of all Americans.”
Highlights of the proposed rules can be found here. A flowchart of whether a prescription can be prescribed via telemedicine can be found here.
The DEA has requested public input regarding these NPRMs. Comments are due on March 31, 2023.