ATA Action, the affiliated trade organization for the American Telemedicine Association (ATA), the only organization “completely focused on advancing telehealth,” recently sent two statements to the Drug Enforcement Administration (DEA) about the agency’s proposed rules (here and here) regarding the remote prescribing of controlled substances. Throughout the two letters, ATA Action outlined suggestions for ways that the draft rules could be improved to maintain mechanisms to prevent diversion while also ensuring that patients do not lose access to their necessary treatments.
The ATA Action letters point to patients who either are unable to, or do not wish to, seek treatment in person. Those individuals “will fall through the cracks under these rules, creating a significant and avoidable public health crisis.”
“We appreciate DEA’s responsibility to write rules that provide effective controls against diversion and protect public health and safety but believe that the requirement that a patient see a clinician in-person is not an effective control against diversion and, instead, simply limits access to legitimate health care,” noted Kyle Zebley, Executive Director of ATA Action, in the letters to the DEA. “We are concerned that in-person requirements will exacerbate existing inequities in the health care system, as it will only serve patients who have the ability to see an in-person provider and misses the point that telehealth provides the unique ability to increase access to care to previously left-behind populations.”
The letters note that every state allows a clinician and provider to establish a valid relationship via telehealth and that a relationship established via technology is “just as legitimate as one established in-person” and that removing this option will harm patients. Instead, the letters argue, the DEA should allow state law and clinical practice standards to control while tracking and monitoring DEA-licensed telemedicine providers in the same way the agency already does for in-person providers.
Zebley also points to potential cost inefficiencies. If a patient has established a relationship with a virtual provider, to require them to establish care with an in-person prescriber just for the sake of a prescription, it may “drive unnecessary utilization of visits without clinical need simply to satisfy the requirement, thereby generating extra cost that could have been avoided.” A potential solution is having the telehealth provider attest that an in-person visit was not necessary for the service provided and ensure that is documented in the medical record.
The letters also note that the DEA should not limit the issuance of prescriptions to the FDA-approved indications contained in the FDA-approved labeling as “it is legal and common for clinicians to use their clinical judgment to prescribe medicines ‘off-label’” and by limiting clinical judgment in this way, it would not only not prevent diversion (which is the DEA’s goal) but it would also likely result in “diminished access to care for necessary medications.”
“We believe that not creating a special registration process for providers wanting to practice legitimate telemedicine is a missed opportunity for both expanded access to care and for DEA’s ability to identify providers operating legally and appropriately from those that are not. Under a special registration regime, DEA could track and manage legitimate providers and therefore more easily identify illegitimate ones,” Zebley concluded. “This could also solve the issue for pharmacists if they were able to access a list of prescribers who had registered with DEA. One course of action to support the removal of the in-person requirements would be to replace the in-person requirements with the statutorily required special registration process.”
The ATA Action Letter to the DEA regarding the Expansion of Induction of Buprenorphine via Telemedicine Encounter can be found here and the ATA Action Letter to the DEA regarding Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Exam can be found here.
The comment period for the DEA proposed rules closed on March 31, 2023. More than 37,000 comments were submitted in response to the proposed rules.
Other Responses
The American Psychiatric Association (APA) also submitted letters in response to the two proposals (here and here) as did the American Society of Health System Pharmacists (ASHP).