The Drug Enforcement Administration (DEA) recently announced proposed permanent rules for prescribing controlled medications through telemedicine. This expands patient access to therapies beyond the COVID-19 public health emergency measures scheduled to end in May that assured patients had access to necessary drug products containing controlled substances during the pandemic.
The proposed rules, developed with the U.S. Department of Health and Human Services (HHS) and in close coordination with the U.S. Department of Veteran Affairs, extend many of the flexibilities adopted during COVID-19 with appropriate safeguards. They do not effect:
•Telemedicine consultations that do not involve controlled substances
•Telemedicine consultations by a medical practitioner who has previously conducted an in-person examination of the patient.
•Telemedicine consultations and prescriptions by a medical practitioner to whom a patient has been referred, as long as the referring physician has previously conducted an in-person medical examination of the patient.
For the subset of patients who haven’t been seen by a healthcare professional and require a controlled medication, the DEA will allow a 30-day supply of Schedule III non-narcotic controlled medications or a 30-day supply of buprenorphine for the treatment of opioid use disorder.
“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 online overprescribing of controlled medications that can cause harm.”
HHS Secretary Xavier Becerra said that there are millions of Americans “particularly those living in rural communities, who face difficulties accessing a doctor or healthcare provider in person.”
The proposed telemedicine rules would also expand the DEA’s goal of allowing access to medication for opioid use disorder to anyone in the country who needs it. Milgram said the telemedicine regulations will continue to expand access to buprenorphine for patients with opioid use disorder.
According to Axios, a report from the National Institutes of Health last August found that people with opioid use disorders who received telehealth visits had a lower risk of overdosing. Unintentional overdose deaths involving buprenorphine didn’t rise because of prescribing flexibility according to a recent JAMA Network Open study, causing some substance abuse experts to question the rationale of DEA’s new rules.
After a six-month grace period, the rules would halt a patient’s ability to receive some controlled substances, including Adderall and Oxycontin, via telemedicine if the patient has never been seen in person. The exception is buprenorphine. A 30-day supply could still be obtained before a required in-person exam for refills.
Experts question how pharmacists will be able to determine if a patient has seen a doctor in person before filling a prescription for controlled medication, since a system with that information doesn’t exist. And critics point out that people with disabilities may have a hard time visiting a doctor because of inadequate parking and building access. “The DEA should have made an allowance for people to continue their medication if they tried to see a doctor, and couldn’t,” said Fred Muench, a clinical psychologist and senior advisor at the Partnership to End Addiction, according to Axios.
The DEA has given the public 30 days to comment on their proposals before drafting final guidance. So far, people have submitted more than 200 responses in the first week.