The administration decided to delay instituting new restrictions on telehealth medication prescribing that had been proposed with the end of the Covid public health emergency May 11, according to public documents.
Telemedicine prescribing of medications during the pandemic was expanded, allowing people to get medications without physically seeing a provider. But that expansion had been scheduled to expire with the end of the Covid public health emergency, expected on May 11.
Earlier this spring, the Drug Enforcement Administration posted new proposed rules, allowing some telemedicine prescribing but with more restrictions than the pandemic rules, to go into effect with the end of the emergency. But the new proposed restrictions brought widespread opposition and fear of dire consequences for people taking stimulants like Adderall and Ritalin, anti-anxiety medications like Xanax, opioid withdrawal aids like buprenorphine, hormones like testosterone for low hormone levels or gender transition, and many other controlled substances.
On May 3, D.E.A. Administrator Anne Milgram issued a statement saying: “The Drug Enforcement Administration received a record 38,000 comments on its proposed telemedicine rules. We take those comments seriously and are considering them carefully. We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities while we work to find a way forward to give Americans that access with appropriate safeguards.
“For this reason, last week, D.E.A., in concert with the Department of Health and Human Services, submitted a draft Temporary Rule to the Office of Management and Budget entitled ‘Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.’ Further details about the rule will become public after its full publication in the Federal Register.”
It is not clear how long the delay will last, or what the final shape of the “telemedicine flexibilities” policy will take.
As we reported earlier, telehealth prescribing exploded during the pandemic. While many millions of people benefited, by being able to get prescriptions without physically visiting their doctors, there were also widespread criticisms of such companies as Cerebral, which is now under federal investigation for prescribing medications online. Patients said Cerebral had mishandled their cases, and the president of the company was removed a year ago. Another A.D.H.D. health teleprovider, Done, is also under federal investigation.
Patient harm predicted
Before the delay was announced, people involved in telemedicine prescribing said that if the new regulations made it too hard to get medications, patients would be forced to go without and fall into crisis. Others might go to the black or gray market, where medications are obviously not quality-controlled and often contain things like fentanyl, experts predicted.
Larger questions about D.E.A. regulation of health issues also came to the fore during the discussion. “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,” said Nathaniel M. Lacktman, partner at the law firm Foley & Lardner and chair of the telemedicine and digital health industry team at the firm,
“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.”
