People can continue getting telemedicine prescriptions as they have been during the Covid pandemic, as the Drug Enforcement Administration said it would continue the pandemic-induced prescribing flexibilities for six months.
The D.E.A. said in a statement of proposed new rules that it would make no immediate changes in the practice for any existing telemedicine prescribing relationships, and for any that are established on or before Nov. 11, 2023.
Beyond that, it seems clear that some change will be proposed; the announcement mentioned a “final set of regulations” to follow.
Before the pandemic, telemedicine prescribing was governed by the Ryan Haight Act, requiring a doctor to physically see a patient at least once before prescribing controlled substances like Adderall and Ritalin for attention deficit hyperactivity disorder; testosterone for hormone deficiencies and gender transition; Xanax and other benzodiazepines for anxiety; buprenorphine for opioid withdrawal; and others.
During the pandemic, telemedicine prescribing without a physical visit was allowed. But with the end of the public health emergency May 11, that flexibility was due to end. Earlier this spring, the D.E.A. proposed new rules requiring in-person visits under some circumstances, raising the possibility that people on such medications would suddenly be unable to get them without an in-person visit.
Doctors said the change would be impossible to put into effect for logistical reasons, including a shortage of doctors, difficulties in making and keeping appointments inside of a 30-day period, and confusion surrounding such a big change with medications for people who depend on them.
The proposed regulations brought a flood of comments — more than 38,000, the D.E.A. said — and resulted in a delay for the new restrictions last week, without knowledge of what would come next.
New regulations same as old
The new regulations issued Tuesday are basically the same as the old ones — for six months.
The D.E.A. statement Tuesday said:
- “The full set of telemedicine flexibilities regarding prescription of controlled
medications as were in place during the COVID-19 PHE will remain in place through
November 11, 2023. - “Additionally, for any practitioner-patient telemedicine relationships that have been or
will be established on or before November 11, 2023, the full set of telemedicine
flexibilities regarding prescription of controlled medications as were in place during
the COVID-19 PHE will continue to be permitted via a one-year grace period through
November 11, 2024. In other words, if a patient and a practitioner have established a
telemedicine relationship on or before November 11, 2023, the same telemedicine
flexibilities that have governed the relationship to that point are permitted until
November 11, 2024.”
“In the meantime, D.E.A. is continuing to carefully evaluate the comments received on the
[proposed regulation] and anticipates implementation of a final set of regulations permitting the practice of telemedicine under circumstances that are consistent with public health, safety, and effective controls against diversion; the goal of this temporary rule is to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as allowing adequate time for providers to come into compliance with any new standards or safeguards.”
The final set of regulations would presumably be subject to the same comment period as the proposals earlier this year, which brought the flood of comments and objections.
Should D.E.A. be in charge of prescribing?
One byproduct of the events surrounding telemedicine prescribing is that serious questions were raised about whether the Drug Enforcement Administration, a wing of the Justice Department involved in policing drugs, should be in charge of availability of medications.
Nathaniel M. Lacktman, partner at the law firm Foley & Lardner and chair of the telemedicine and digital health industry team at the firm, said: “There have been a number of opinion articles in The New York Times and The Washington Post about how this has just been a complete failure, about how the existence of D.E.A. did not prevent the opioid crisis and has not been helpful.
“Just questioning even its role: Using a policing agency to have oversight over health care. Some people are already asking to switch that responsibility to an entity like the F.D.A.,
which is a health organization and not a policing organization.”
