As we look back on the lockdown phase of the Covid-19 pandemic, we learned that telehealth is a legitimate, safe, high-quality mode of care delivery for a number of clinical applications. Before 2020, most telehealth interactions fit into the category known as virtual urgent care, representing 0.19 percent of all health insurance claims. But since 2021, the Fair Health tracker shows that telehealth has accounted for about 5 percent of all health insurance claims, with about 70 percent for behavioral health.
All this to say, new opportunities for virtual care continue to emerge, accounting for the stable rise in overall telehealth claims and resulting in many more clinicians providing needed healthcare services to patients outside of their geographic area. Hence, given that much of this care involves chronic illness management, there is an increase in prescriptions flowing to pharmacies from care providers in different geographic areas.
Let me put a fine point on it with an illustration:
Despite a comprehensive virtual consultation and valid prescription from a telehealth provider specializing in substance use disorder (SUD) treatment, a patient, let’s call her Emma, struggles to get buprenorphine, medication crucial for her recovery from opioid addiction. Today, pharmacists fear potential repercussions for filling a prescription from a telehealth provider in another state. This is due to a “red flag” regarding the geographical distance between patient, provider, or pharmacist, which remains a significant hurdle, as pharmacists increasingly distrust prescriptions from remote providers for controlled substances like buprenorphine.
The regulation of these matters, of course, falls under the jurisdiction of the U.S. Drug Enforcement Administration (DEA). While I fully recognize that the DEA has the best of intentions, our goal must be to ensure patients have access to needed care. It is rumored that there are new rule(s) in the works that, if not designed thoughtfully, could unintentionally impose additional requirements on pharmacists, leaving patients like Emma in a precarious position. Without access to her prescribed buprenorphine, she faces the risk of returning to more harmful substances, undoing her efforts to seek treatment and recover.
I can’t think of a valid reason to insist that a prescribing provider be in the same state as the pharmacy, can you?
Which brings us back to our hypothetical patient. While intended to regulate and control, new DEA rules may inadvertently create barriers to care for patients like Emma, who rely on telehealth for access to essential treatment. Emma’s case emphasizes the necessity for the DEA to consider the practical impact of its regulations on patient care, especially for vulnerable populations relying on telehealth for SUD treatment.
Removing unintentional barriers
As the DEA carefully considers requirements for the remote prescribing of controlled substances, I can’t resist offering some guidance. My goal is to caution against creating unintentional barriers to needed care for patients and providers who are in relationships across distance.
Following is a summary of the recommendations for a Special Registration process for the remote prescribing of controlled substances, as outlined by my colleagues at the American Telemedicine Association (ATA) and ATA Action:
- The Special Registration process should work in conjunction with the existing registration process, such as including a modifier or ‘stamp’ (e.g., “T” for telemedicine) to the prescriber’s DEA number, indicating a special telemedicine registration.
- Telemedicine providers should not be required to maintain local addresses in every state where they practice.
- Special Registration should include the elements DEA needs to monitor for illegitimate practitioners and illegal prescribing practices.
- Special Registration should not be limited to any specific specialty or treatment condition. Schedule II prescribing could involve additional oversight but should not have additional restrictions.
- Dispensers (pharmacies and pharmacists) should be able to identify legitimate prescribers who have a current Special Registration.
- 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.
There are two points I’d like to call out regarding the above Special Registration recommendations.
First, a valid prescription is a valid prescription, and the fact that one was issued via telemedicine makes it no less so. If the DEA maintains the proposed ‘stamp’ on prescriptions indicating they were issued via telemedicine, this should serve as a marker of legitimacy, not a red flag. The ‘T’ modifier on a prescriber’s registration number should specify to pharmacists that the telehealth provider has undergone Special Registration, validating the prescription regardless of geographic location.
Additionally, to help build pharmacists’ trust in filling remote prescriptions, the ATA and ATA Action also recommend the DEA establish a form of safe harbor for pharmacists who dispense prescriptions based on the Special Registration status of telehealth providers. This would assure pharmacists that they are fulfilling legitimate prescriptions even if the provider is in a different geographic area — and importantly, eliminate a barrier to patient access to necessary medications.
It is incumbent on the DEA to strike a balance between ensuring legitimate healthcare providers may prescribe needed medications to their patients while preventing diversion, all the while expanding access to essential virtual care services for our patients in need.
It’s likely that interagency review of the DEA’s rule(s) is imminent, within the next couple of weeks. A public comment phase will follow. The DEA has an important and daunting job that will determine the fate of millions of patients. I join the countless healthcare providers, pharmacists, patients, and their families in urging the DEA to carefully consider the implications of any new regulations and ensure they do not inadvertently create barriers to care.
This piece was written by Joseph Kvedar, MD, Senior Advisor of Virtual Care at Mass General Brigham, and Professor of Dermatology at Harvard Medical School. It was originally published on his blog page, Reinventing Healthcare.