DEA Appears Open to Tele-Script for Certain Controlled Substances
On August 7th, the Drug Enforcement Agency (DEA) issued a notice of meeting regarding telemedicine prescription of certain controlled substances (Schedule II only). The meeting(s) will be conducted as “listening sessions”, conducted Tuesday, September 12th, and Wednesday, September 13th from 9 a.m. to 5:30 p.m. at the DEA Headquarters (located at 700 Army Navy Drive, Arlington, VA). Participants must pre-register using this link, before or on August 21st. In-person requests will be granted via lottery and the sessions will be live-streamed. Similarly, those wishing to provide limited oral presentation, either in-person or via live-stream must also fill out the form. Again, these will be selected by DEA personnel based upon quality of summary of presentation. Presentations may be made by anyone with an interest in and expertise in the subject matter. The DEA has asked for feedback on the following questions:
If telemedicine prescribing of schedule III–V medications were permitted in the absence of an in-person medical evaluation, what framework, including safeguards and data, with respect to telemedicine prescribing of schedule III–V medications do you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?
Should telemedicine prescribing of schedule II medications never be permitted in the absence of an in-person medical evaluation? Are there any circumstances in which telemedicine prescribing of schedule II medications should be permitted in the absence of an in-person medical evaluation? If it were permitted, what safeguards with respect to telemedicine prescribing of schedule II medications specifically would you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?
If practitioners are required to collect, maintain, and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies, and other third parties?
If pharmacies are required to collect, maintain, and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies, and other third parties?
The listening sessions come as a direct result of the DEA receiving truly unprecedented responses to proposed rules published in March, in anticipation of the end of the COVID-19 public health emergency, and, thus, the DEA’s telemedicine waiver issued at the beginning of the COVID-19 pandemic. In all, the DEA received almost 40,000 comments across the proposed rules with much focus on the General Telemedicine proposed rule. We covered the content of those rules (and why they were a step backward as written) in March. In particular, we expressed concern over returning to pre-pandemic limitations on telemedicine when the pandemic-related waiver did not prove any spike in diversion and did, indeed, improve access to medication assisted substance use treatment for many patients. Along similar lines, because testosterone is considered a controlled substance, such a return at the height of bias-driven, state-based legislation limiting access to certain gender affirming care would have a disproportionately harmful impact among transgender men and undermine President Biden’s commitment to combat these hateful efforts.
The relationship between the DEA and harm reduction advocates has been long and fraught. Many harm reduction advocates criticize the role of law enforcement’s actions, particularly that law enforcement agency, working against best practices in public health, even those best practices recognized by federal public health agencies. For example, a couple of weeks ago, we highlighted the Substance Abuse Mental Health Administration’s document (currently open to public comment) aimed at formalizing certain policy positions, entitled Harm Reduction Framework. Nowhere in the “framework” is the conflict with law enforcement positions addressed.
Putting more pressure still on the DEA’s absolute refusal to meet its commitment from 2009 to introduce meaningful telemedicine rules (in response to passage of the Ryan Haight Online Pharmacy Consumer Protection Act) is the fact that the stimulant medication shortage is at its worst. Things are so bad the U.S Food and Drug Administration (FDA) and DEA issued a joint letter on August 1st to further detail actions being taken to address the shortage and consumer struggles. The problem with the letter is it is largely bypasses the responsibility the DEA has in the current situation. Leaning into a claim that manufacturers haven’t filled their annual quota limits in production and pointing fingers at an increase in legitimate prescription of stimulants to manage conditions like attention deficit hyperactivity disorder (ADHD), the letter fails to recognize that the DEA also places extraordinary limits and scrutiny on pharmacies dispensing stimulant medications. Known as “drug diversion”, the idea behind monitoring pharmacies has some merit when viewed under the lens that pharmacies have a responsibility to limit index events like those “pill mills” associated with the opioid epidemic. However, the DEA doesn’t take responsibility for pharmacy raids or strict enforcement against prescribing providers working to keep patients from turning to street supplies by providing legitimate prescriptions.
For the DEA to be a meaningful partner in combatting both illicit and harmful drug use and overdoses and help to address drug shortages, limiting harmful diversion, the agency needs to consider a dramatic shift from an “all drugs are bad, and the people who use them are bad” mindset. There needs to be a thoughtful “medium, wherein stakeholders other than law enforcement can engage in distinguishing best practices in supply chain security and harm reduction and readily identifying criminals taking advantage of patients seeking care by any means they can achieve it – including illegal and illicit channels.
Patient advocates outside of harm reduction and substance use disorder focuses and the industry stakeholders who serve these patients would do well to consider engagement in these and other opportunities to help re-shape and re-imagine the DEA’s role, ideas, and programs to better serve the public at large, better secure the supply chain and limit disruptions, and ensure patients can have ready, reliable, and modernized access to the care we need.
