Recently, the American Telemedicine Association (ATA) Action submitted comprehensive recommendations to the United States Drug Enforcement Administration (DEA) regarding a Special Registration process for prescribing controlled substances via telemedicine encounters.
ATA Action believes that the DEA should consider two principles when regulating the prescribing of controlled substances via telemedicine: (1) clinical practice should not be limited by non-clinical decision-makers and (2) telemedicine is not a type of care, but a modality. Therefore, the group argues that any rules made should account for the use of technology as a modality, without arbitrary restrictions.
ATA Action further noted that while minimum clinical standards, best practices, and quality should be factors, they should not vary across modalities for the same service, even though there may be advantages and disadvantages to receiving a service remotely. For example, advantages of remote service may include more standardized care across a national practice, which may lead to higher quality, more convenience, and accessibility for the patient and provider, as well as potentially reduced infrastructure costs, while a disadvantage to remote service may be the “increased reach that bad actors may have using technology, which speaks to DEA’s concerns or diversion and overprescribing.”
ATA Action outlined seven recommendations to the DEA for a Special Registration process for telemedicine prescribing of controlled substances without a prior in-person visit:
- The Special Registration process should work in conjunction with the current registration process.
- Special Registration should be an optional supplemental form and should result in a modifier on a practitioner’s DEA number. The modified number is what will need to be used when issuing a prescription via telemedicine.
- Telemedicine providers should not be required to maintain local addresses for every state in which they practice.
- The value of telemedicine is “only fully captured through the ability to practice across state lines” and improving access to care in more remote areas can only occur when technology can be used to bridge those gaps.
- Special Registration should include the elements that the DEA needs to monitor for illegitimate practitioners and illegal prescribing practices.
- This includes personal/business information (address, phone, email, provider identification number), state authority (state practice licenses, state controlled substances registration, states of practice, proof of malpractice insurance), background check, and certain attestations.
- Special Registration should not be limited to specific specialties or treatment conditions. Additionally, Schedule II prescribing may involve additional oversight but should not include any additional restrictions.
- Pharmacies and pharmacists should be able to identify prescribers who have a current Special Registration.
- This is in response to the “red flags” that pharmacies and pharmacists have been trained to acknowledge in light of the opioid crisis. This Special Registration process should be used to help dispensers identify legitimate telemedicine prescribers and have confidence in prescriptions issued by Special Registration providers.
- The location of the patient should not require any registration unless otherwise required because controlled substances are dispensed or administered at that site.
- The Special Registration process should not place any arbitrary limits on a clinician’s ability to practice within the scope of their authority.
- This includes no limits to the number of patients a provider can treat or the time period for which a provider can issue prescriptions.
“ATA Action’s comments to DEA’s March 2023 proposed rules specifically detail why in-person mandates restrict access to care and how restricted access to telemedicine will increase patient harm and diversion risk. We appreciate DEA’s efforts to review and incorporate stakeholder feedback on those comments, including considering the creation of a Special Registration process,” noted Kyle Zebley, Executive Director, ATA Action, in the document submitted to the DEA. “We maintain that in-person requirements are not a clinically appropriate or effective way to limit diversion and our first preference would be to permanently waive the in-person requirement as done during the COVID-19 public health emergency.”
ATA Action also urged the DEA to “consider realistic timelines when implementing these new processes.”