Substance use disorder (SUD) treatment providers, particularly those focused on opioid use disorder (OUD), received significant news this week that could help expand access to care for those struggling with addiction. On Wednesday, the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) announced a final rule that allows clinicians to prescribe buprenorphine—a key medication for opioid use disorder treatment—via telehealth or even audio-only telehealth visits for up to six months. This final rule, officially titled Expansion of Buprenorphine Treatment via Telemedicine Encounter, has been finalized and published in the Federal Register, making it a concrete step forward in making addiction treatment more accessible through virtual means.
A New Era for Virtual Prescribing: Convenience and Challenges
This new rule could potentially revolutionize the way that MOUD (medications for opioid use disorder) are prescribed, especially for individuals who may live in remote or underserved areas where in-person treatment options are limited. The ability to prescribe buprenorphine via telehealth for up to six months without the need for an in-person visit is an important development that can enhance access to much-needed opioid use disorder treatment. The rule is aimed at ensuring that patients who have started their recovery journey through telehealth can continue receiving consistent care, reducing barriers such as transportation or the inability to take time off work for in-person visits.
However, while many in the addiction treatment community see this as a step in the right direction, some providers are expressing concern over ambiguities within the rule. There’s a growing worry that certain aspects of the regulations could lead to complications in navigating the legal landscape for MOUD prescribing down the line. The primary concern centers on how the new rule interacts with other existing regulations and how it will be enforced. These uncertainties could make it difficult for providers to ensure they remain compliant with the law, which might complicate the overall prescribing process in the future.
Expanding DEA’s Authority: The Proposed Special Registration Framework
In addition to the finalized rule allowing buprenorphine prescribing via telehealth, the DEA has also released a proposed rule that would establish a special registration framework for telemedicine providers. This proposed rule, titled Special Registrations for Telemedicine and Limited State Telemedicine Registrations, aims to expand the DEA’s authority to regulate prescribers and telemedicine companies. Under this framework, certain practitioners would be allowed to prescribe controlled substances via telehealth, provided they meet specific requirements outlined by the DEA. The framework would also dramatically reduce the need for physical offices in each state and reduce state registration fees for providers, which are currently as high as $1,000 per state.
Dr. Brian Clear, chief medical officer at Bicycle Health—a provider that offers telehealth-based MOUD treatment—shared his perspective on the proposal. He noted that while the rule could lead to significant cost savings and operational efficiencies, it also increases the DEA’s regulatory oversight, adding an extra layer of complexity for practitioners and telehealth companies. Clear highlighted that telehealth providers would likely need to hire additional legal experts to navigate the nuances of the new framework, especially if they are required to maintain multiple DEA registration numbers for different states.
The framework also aims to eliminate the need for clinicians to maintain practice locations in all 50 states, a process that is both costly and time-consuming. Clear believes the proposed rule will lead to greater efficiencies by streamlining the process of treating patients across state lines, though the added legal complexities may pose a challenge for smaller providers. While some see this as a more flexible approach to telehealth prescribing, others are wary of the administrative burden it could place on their operations.
The Special Registration Framework: A Double-Edged Sword?
One of the primary components of the special registration framework is that providers and telehealth companies may be required to maintain multiple DEA registration numbers. In some cases, providers may need to have up to five separate registration numbers depending on the medications they prescribe and whether they belong to larger organizations. This requirement has raised concerns among some providers, particularly smaller ones, who may struggle to meet these new demands without additional support or resources.
Kyle Zebley, senior vice president of public policy at the American Telemedicine Association, weighed in on the complexity of the rule. He pointed out that while the special registration framework offers flexibility, it also includes provisions that may be difficult to operationalize, particularly for Schedule II controlled substances. One of the most concerning elements of the rule, according to Zebley, is the requirement for special registrants to verify the identity of patients and conduct a nationwide Prescription Drug Monitoring Program (PDMP) check for all 50 states and U.S. territories. This requirement, while slated to go into effect three years after the rule becomes final, could be a logistical nightmare for telehealth providers, especially those who serve patients across multiple states.
Additionally, while the special registration framework offers more flexibility than the previous regulations, some believe that its complexities could limit the ability of smaller telehealth providers to participate in virtual MOUD prescribing. As a result, there’s concern that certain legal barriers might inadvertently limit the reach of telehealth services, particularly for those patients who are most in need of accessible opioid use disorder treatment.
What Does the Future Hold for Virtual Buprenorphine Prescribing?
As the final buprenorphine prescribing rule goes into effect on January 17, the immediate impact on providers and patients is largely positive, especially for those seeking treatment for opioid use disorder. Providers are now able to offer buprenorphine prescriptions via telehealth for up to six months without requiring an in-person visit. This is a significant improvement over the previous regulations, which required in-person visits for patients to receive prescriptions.
Despite this positive change, there are still questions surrounding the long-term impact of the rule. One of the biggest questions is whether the rule will apply only to new patients or if it will also allow providers to continue treating existing patients under the same telehealth terms. Additionally, after the six-month period, patients will be required to either visit their provider in person or transfer their care to another provider authorized to continue telemedicine prescribing. For some providers, the inability to continue offering telehealth treatment beyond six months could be a significant setback, particularly if they face issues such as clinician vacations, retirements, or coverage gaps.
Jessica Rigsby, vice president of legal and compliance at Ophelia, voiced concern that the rule, while beneficial, may not be enough to fully support ongoing opioid use disorder treatment through telehealth. Without a clear plan for continuing telehealth beyond six months, the rule’s impact may be limited in scope. Additionally, cross-coverage issues could arise, particularly if a clinician is unavailable or leaves their practice, disrupting patient care.
For now, providers will continue to navigate the complexities of the current system while waiting for further clarity on the special registration framework and its future implementation. As Dr. Clear pointed out, while the rule offers a temporary solution, the longer-term legal uncertainties could hinder some providers’ ability to fully embrace telehealth prescribing for opioid use disorder treatment.
Conclusion: Positive Steps Forward, But Much Still to Unpack
In conclusion, the DEA’s final rule allowing for the prescription of buprenorphine via telehealth for up to six months is a much-needed expansion of access to opioid use disorder treatment. It offers hope for patients who may have struggled to access in-person care and provides more flexibility for telehealth providers. However, the new rule comes with complexities and uncertainties that could create challenges for some providers, particularly smaller ones. The proposed special registration framework may further complicate the landscape, although it could also streamline certain aspects of prescribing across state lines.
As the addiction treatment community waits for further clarification and for the full implementation of the proposed rules, there’s optimism that the growing focus on virtual care will continue to help address the opioid crisis. The need for accessible, effective opioid use disorder treatment remains high, and the hope is that these regulatory changes will improve patient care and provide a clearer path forward for both providers and patients. However, it’s clear that there are still many legal, operational, and logistical hurdles to overcome before telehealth prescribing can fully thrive in this space.
