On February 24, Drug Enforcement Administration announced proposed permanent rules for the prescribing of controlled medications via telemedicine, expanding patient access to critical therapies beyond the scheduled end of the COVID-19 public health emergency. The public will be able to comment for 30 days on the proposed rules.
The proposed rules – developed with the U.S. Department of Health and Human Services and in close coordination with the U.S. Department of Veterans Affairs – propose to extend many of the flexibilities adopted during the public health emergency with appropriate safeguards.
The proposed rules are only for Schedules III-IV medications, so they include buprenorphine, but not methadone, which is Schedule II.
The proposed rules do not affect:
- Telemedicine consultations that do not involve the prescribing of controlled medications.
- Telemedicine consultations by a medical practitioner that has previously conducted an in-person medical examination of a patient.
The proposed rules also would not affect:
- Telemedicine consultations and prescriptions by a medical practitioner to whom a patient has been referred, as long as the referring medical practitioner has previously conducted an in-person medical examination of the patient.
The proposed rules would provide safeguards for a narrow subset of telemedicine consultations—those telemedicine consultations by a medical practitioner that has: never conducted an in-person evaluation of a patient; AND that result in the prescribing of a controlled medication. For these types of consultations, the proposed telemedicine rules would allow medical practitioners to prescribe:
- a 30-day supply of Schedule III-V non-narcotic controlled medications;
- a 30-day supply of buprenorphine (which the DEA regards as a narcotic) for the treatment of opioid use disorder
without an in-person evaluation or referral from a medical practitioner that has conducted an in-person evaluation, as long as the prescription is otherwise consistent with any applicable Federal and State laws. The proposed rules are explained in further detail for patients and medical practitioners on DEA.gov.
“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.”
The proposed telemedicine rules also further DEA’s goal of expanding access to medication for opioid use disorder to anyone in the country who needs it. “Medication for opioid use disorder helps those who are fighting to overcome substance use disorder by helping people achieve and sustain recovery, and also prevent drug poisonings,” said DEA Administrator Milgram. “The telemedicine regulations would continue to expand access to buprenorphine for patients with opioid use disorder.”
The full text of the proposals may be found here and here. The public has 30 days to review and comment on the proposals, which DEA will then consider before drafting final regulations. DEA is appreciative of the public’s feedback.
For more information on DEA’s continued efforts to expand access to medications used in treatment for those suffering from opioid use disorder, visit: DEA’s Commitment to Expanding Access to Medication-Assisted Treatment.
Additional resources for patients can be found here:
- Is My Prescription a Controlled Medication? Controlled-Non Controlled List (dea.gov)
- Can My Medication be Prescribed through Telemedicine? Controlled Substance Guidance (dea.gov)
Additional resources for practitioners can be found here:
- Proposed Rules Summary Telemedicine Rules Summary.pdf (dea.gov)
- Proposed Rules Highlights for Medical Practitioners Telehealth Highlights Medical Practitioners.pdf (dea.gov)
Once the proposed rules are published, the Drug Enforcement Administration encourages that all comments be submitted through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the Web page or to attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments.