DEA Considering More Changes to Telehealth Prescribing Rules
/By Pat Anson, PNN Editor
The U.S. Drug Enforcement Administration will hold two public hearings next month – what it calls “listening sessions” – to consider if providers should continue prescribing controlled substances through telehealth without first requiring patients to have an in-person medical evaluation.
Patients are currently allowed to get a controlled medications without visiting their doctor under emergency telehealth rules adopted three years ago at the start of the Covid-19 pandemic. Controlled substances include many opioids, stimulants, sedatives, steroids, and addiction treatment medications such as methadone and buprenorphine (Suboxone).
“DEA recognizes the importance of telemedicine in providing Americans with access to needed medications, and DEA has been, and remains, committed to expanding access to telemedicine in a way that puts patients — and their safety — first, is simple to understand and apply, reflects technological advancements, and is consistent with lessons learned during the COVID–19 PHE and the ongoing opioid epidemic,” the agency said in a statement.
Rules that are “simple to understand and apply” may be the key issue. In March, the DEA proposed changing the telehealth rules to reimpose “guardrails” on Schedule II opioids such as oxycodone and hydrocodone. For those medications, a patient would first be required to have an in-person meeting with a doctor, with refills then allowed via telehealth. Other drugs that are classified as Schedule III, IV or V substances could initially be prescribed for 30 days via telehealth, but any refills would require an in-person meeting.
The proposed rule changes are so confusing and drew so much opposition that the DEA delayed implementing them until this November. Next month’s public hearings are another sign the agency is still uncertain what to do.
In a notice published in the Federal Register, the DEA said it was open to creating a special registration process that would allow providers to continue prescribing “some controlled substances” without seeing patients in-person. The agency didn’t specific which controlled substances it is referring to.
“DEA is open to considering — for some controlled substances — implementation of a separate Special Registration for telemedicine prescribing for patients without requiring the patient to ever have had an in-person medical evaluation at all,” the DEA notice said.
“DEA also observes that making permanent some telemedicine flexibilities on a routine and large-scale basis would potentially create a new framework for medicine that fundamentally expands access to controlled substances in a way that warrants a new framework for accountability based, in part, on increased data collection and visibility into prescription practices in order to ensure patient safety and prevent diversion in near-real-time.”
Opioid Diversion Rare
Contrary to popular belief, opioid diversion is rare. Using data gathered from prescription drug monitoring programs (PDMPs), pharmacies, hospitals and others in the drug supply chain, the DEA’s most recent estimate is that less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) is lost, stolen or diverted to someone they were not prescribed to.
Opioid prescriptions are also harder to obtain and there are chronic opioid shortages around the country, so few pain patients are willing to part with their legally prescribed medications. Counterfeit medications and other street drugs made with illicit fentanyl are the real problem, which the DEA “listening sessions” won’t address.
The public hearings will be held on September 12 and 13 at DEA headquarters in Arlington, Virginia. Medical practitioners, patients, pharmacists, drug makers, distributors, law enforcement, and other interested parties can express their views either in-person or by video teleconference. The public hearings will also be streamed live online.
The DEA is seeking input on these key questions:
Should telemedicine prescribing of Schedule II medications be permitted without an in-person medical evaluation? If it is permitted, what safeguards would you recommend to ensure patient safety and prevent diversion?
If telemedicine prescribing of Schedule III–V medications is permitted without an in-person medical evaluation, what safeguards and data should be collected for those substances?
To register as a speaker, click here. The deadline for registering is August 21.
