On January 16, 2025, the U.S. Drug Enforcement Administration (DEA) announced new rules and proposed changes aimed at regulating telemedicine practices and prescription drug distribution. These rules mark an important evolution in how healthcare providers, telemedicine companies, and patients interact with controlled substances—particularly in the wake of the COVID-19 pandemic and expiring flexibilities. If you are a healthcare provider, telehealth facilitator/platform, or organization engaged in prescribing controlled substances, it’s essential to understand the nuances of these changes, as they will directly affect your operations.
Special Registration for Telehealth Providers: A Long-Anticipated Change
One of the most significant and anticipated elements of the DEA’s new regulations is the introduction of special registration requirements for telemedicine providers who prescribe controlled substances. While telemedicine has seen explosive growth, particularly during the COVID-19 pandemic, the DEA’s special registration process was being developed well before the public health emergency (PHE). However, the prescribing flexibilities and waivers that were implemented during the PHE rendered the idea of a special registration process somewhat moot, at least for the duration of the PHE. Given the expiration of these flexibilities, the DEA has now proposed a formal registration system for telemedicine providers prescribing controlled substances. The special registration process is designed to enhance accountability, verify the legitimacy of telehealth providers, and safeguard patients from potential misuse or fraudulent prescriptions.
How the Special Registration Process Will Work
The proposed rule indicates that there would be three types of Special Registrations: (1) a Telemedicine Prescribing Registration, authorizing qualified clinician practitioners to prescribe Schedule III-V controlled substances via telemedicine, (2) an Advanced Telemedicine Prescribing Registration, authorizing qualified, specialized clinician practitioners (e.g., psychiatrists, hospice care physicians) to prescribe Schedule II-V controlled substances via telemedicine, and (3) a Telemedicine Platform Registration, authorizing covered online telemedicine platforms, in their capacity as platform practitioners, to facilitate dispensing of Schedule II-V controlled substances. Additionally, the special registrant would be required to maintain a State Telemedicine Registration, issued by the DEA, for every state in which a patient is treated by the special registrant, unless otherwise exempted.
The registration process will involve several essential steps and require renewal on a three-year cycle. Providers wishing to prescribe controlled substances via telemedicine must complete an application with the DEA. Here’s a breakdown of the key elements involved:
- Application Submission: Healthcare providers who intend to prescribe controlled substances remotely will need to submit an application to the DEA. The application will ask providers to supply basic information about their practice, including their healthcare credentials, the types of services they provide, and details about their telemedicine operations.
- Criteria for Registration: To be eligible for registration, providers will need to demonstrate the following:
- Licensing and Certification: Providers must be appropriately licensed to practice medicine and prescribe controlled substances in the states where they are operating. Providers will also need to maintain compliance with state-specific telemedicine laws.
- Security and Privacy Standards: Providers will be required to use telemedicine platforms that enable live audio-video telecommunications and meet strict security protocols to protect patient data and ensure that prescriptions are issued securely.
- Clinical Guidelines: Providers must adhere to federal and state clinical guidelines regarding the prescribing of controlled substances. This includes establishing a legitimate patient-provider relationship, conducting necessary evaluations, and ensuring that prescriptions are appropriate for the patient’s condition.
- State Authorization: In some cases, providers may need to obtain approval from the state medical boards not only where the patient is located, but where the provider is physically located at the time that they are practicing. Telemedicine providers who operate across state lines will need to ensure that they comply with the regulations in each state where they are prescribing controlled substances.
- Verification of Compliance: In order to ensure that providers meet the necessary standards for patient care, the DEA will verify that the telemedicine provider adheres to required regulations and the criteria listed above. This verification will include confirming that telemedicine platforms meet privacy and security standards (such as HIPAA compliance), that prescriptions are issued in accordance with federal and state laws, and that the provider has implemented appropriate safeguards to avoid overprescribing or improper prescribing practices.
- Ongoing Monitoring and Reporting: Once registered, telemedicine providers will be required to comply with regular reporting requirements. The DEA will periodically review registered providers to ensure they continue to meet the necessary criteria. This includes ensuring that all prescriptions are monitored for compliance with regulatory standards and sharing prescription data with a newly established National Prescription Drug Monitoring Program (PDMP). The proposed national PDMP will allow for real-time tracking of controlled substance prescriptions and serve as an important tool for both healthcare providers and regulators to monitor interstate prescriptions. Providers who prescribe across state lines will benefit from the ability to access a consolidated database that tracks controlled substances, ensuring that their patients are not receiving multiple prescriptions from different providers.
Why This Matters for Providers and Telehealth Facilitators
The special registration requirements will impact a wide range of healthcare providers, from primary care physicians to addiction specialists, mental health professionals, and pain management experts. Providers who offer controlled substances via telemedicine will need to ensure they meet these new criteria in advance of the effective date.
Additionally, these changes will not only affect the providers themselves but also telemedicine companies and platforms facilitating the prescribing process. For the first time, organizations facilitating telehealth services will also need to undergo a registration process with the DEA to offer their platforms to practitioners who prescribe these substances. While telehealth companies have existed for years, the new rule ensures that telemedicine services are fully integrated within the regulated framework for the distribution of controlled substances.
For those providing telemedicine services—especially in the area of addiction treatment, pain management, and hormone replacement—it is crucial to prepare for these regulatory changes, which could involve changes to standard operating procedures, technology platforms, and patient engagement strategies.
Buprenorphine Final Rule
Another important aspect of the DEA’s announcement is its final rule on Buprenorphine prescribing. Buprenorphine is a commonly prescribed medication for opioid use disorder, and the rule establishes a clear process for healthcare providers to prescribe this medication via telemedicine. Critically, the rule allows a patient to receive a 6-month supply of buprenorphine through a telephone consultation with a provider. Further prescriptions of buprenorphine will then require an in-person visit to a medical provider.
This new rule related to Buprenorphine ordering will become effective thirty days after the rule is published in the federal register, which is expected to be done on January 17, 2025. Thus, providers who are currently prescribing this medication via telehealth will need to familiarize themselves with these requirements and ensure they are in compliance by February 16, 2025.
Veterans Administration Final Rule: Expanding Access to Care
A notable change in the DEA’s rules pertains to the Veterans Administration (VA) and its telehealth capabilities. Under the new final rule, a single in-person encounter with a VA prescriber will now allow that patient to receive continued care through virtual visits with other VA prescribers. VA prescribers are defined as healthcare professionals working within the VA system who have been designated as authorized to prescribe medications to veterans. This rule ensures that veterans will have more consistent and flexible access to care, regardless of their geographic location, while still maintaining oversight and continuity of care through the VA system.
Conclusion
The DEA’s new rules and proposed regulations prescribing controlled substances via telehealth offer the clarity that many companies and prescribers have been awaiting for the past several years in the wake of the PHE. The integration of a national prescription monitoring program and the expansion of telemedicine provider registration requirements will likely have a significant impact on how telehealth platforms and prescribers prepare for and deliver remote care. Providers should begin preparing for these regulatory changes, particularly the final rules regarding Buprenorphine prescribing and compliance with the VA telehealth rule. However, although only a proposed rule at this time, both prescribers and telehealth platforms must be cognizant of the status of the rule regarding special registration. To the extent that this rule is made final, it is likely to require significant administrative oversight to prepare for and obtain the applicable registration.
As always, if your organization is navigating these regulatory changes, it’s crucial to seek legal guidance to ensure full compliance with the DEA’s evolving requirements. Contact Frier Levitt to discuss how these new rules could impact your practice and the steps you must take to stay ahead of the curve. Moreover, if you are interested in submitting comments to DEA regarding the proposed special registration process, either as a prescriber or a facilitator, contact us to discuss this process. Comments must be submitted before March 18, 2025.
