DEA Releases Final Rules on OUD Treatment, Continuity of Care and Proposed Rules for Special Registrations.

Expansion of Buprenorphine Treatment via Telemedicine Encounter

The U.S. Drug Enforcement Administration (DEA) has issued a final rule to update and refine regulations surrounding the prescribing of controlled substances via telemedicine, with a particular focus on balancing public health needs and the prevention of substance misuse. This rule is part of an effort to clarify how the practice of telemedicine, which grew significantly during the COVID-19 pandemic, can continue to support patient access to necessary care without compromising the safety measures associated with controlled substances.

Key Provisions:

1. Telemedicine Flexibilities:
   The final rule provides detailed guidance on how healthcare practitioners can prescribe controlled substances via telemedicine without an in-person consultation. This includes creating a pathway for initial prescriptions for certain controlled substances while ensuring compliance with safety and monitoring measures.

2. Controlled Substances Limitations:
   Specific requirements are outlined for the types and quantities of controlled substances that can be prescribed through telemedicine, particularly for Schedule II medications and substances with a high potential for abuse.

3. Patient Safeguards:

   • Enhanced identity verification processes to ensure that telemedicine prescribing is only provided to verified patients.

   • Mandated consultations and documentation requirements to ensure that telemedicine is used appropriately and that prescriptions align with the medical necessity of the patient.

4. Prescriber Requirements:

   • Practitioners must meet certain criteria to prescribe controlled substances via telemedicine, including registration with the DEA and compliance with state laws.

   • They are also required to maintain records of telemedicine interactions and ensure that these are available for review if necessary.

5. Addressing Opioid Crisis:
   The final rule acknowledges the ongoing opioid crisis and includes provisions designed to reduce the risk of misuse and diversion of controlled substances. These measures include limits on prescription durations and increased monitoring of prescribing patterns.

Specific Provisions for Opioid Use Disorder Treatment

1. Telemedicine Prescribing of Buprenorphine: Practitioners registered with the Drug Enforcement Administration (DEA) are authorized to prescribe Schedule III-V controlled substances approved by the Food and Drug Administration (FDA) for OUD treatment via telemedicine encounters, including audio-only interactions. This provision allows for an initial prescription of up to a six-month supply, divided among several prescriptions totaling six calendar months. Subsequent prescriptions require either an in-person medical evaluation or must adhere to other telemedicine practices authorized under the Controlled Substances Act.

2. Prescription Drug Monitoring Program (PDMP) Review: Before issuing a prescription through telemedicine, practitioners must review the PDMP data of the state where the patient is located during the telemedicine encounter. This step is crucial for assessing the patient's prescription history and preventing potential medication misuse.

3. Patient Identity Verification: Pharmacists are required to verify the identity of the patient before dispensing the prescribed medication. This measure ensures that prescriptions are accurately filled and delivered to the correct individuals, maintaining the integrity of the treatment process.

4. Continuation of Telemedicine Flexibilities: The rule extends certain telemedicine flexibilities that were initially implemented during the COVID-19 pandemic, aiming to prevent lapses in care for patients seeking OUD treatment. These flexibilities are now extended through December 31, 2025, allowing providers to continue utilizing telemedicine for prescribing controlled substances without an initial in-person evaluation.

Feedback from Public and Stakeholder Comments:

The DEA and HHS have incorporated feedback from stakeholders, including healthcare professionals, patient advocacy groups, and state agencies, into the development of this proposed rule. Stakeholders emphasized the need for telemedicine regulations that prioritize patient access while safeguarding against potential misuse of controlled substances.

Support for Telemedicine Access:

A common theme among comments was strong support for preserving telemedicine flexibilities that emerged during the pandemic. Stakeholders noted that telemedicine has become a critical tool for improving access to care in rural and underserved communities. One provider wrote, “Telemedicine has been a lifeline for patients who otherwise would face significant barriers to accessing necessary medications.”

Concerns About Abuse and Diversion:

However, many commenters expressed concerns about the risks of misuse. State agencies and law enforcement groups urged the DEA to implement stricter safeguards to monitor prescribing patterns and ensure accountability. A state medical board official commented, “While telemedicine has clear benefits, we must ensure that it does not become a loophole for the overprescribing of opioids and other high-risk medications.”

Patient Privacy and Access Challenges:

Advocates for mental health and substance use disorder patients highlighted potential challenges related to identity verification and record-keeping requirements. They cautioned that overly burdensome requirements might deter vulnerable populations from seeking care. One advocacy group warned, “We must avoid creating additional barriers for patients who are already navigating complex mental health or addiction issues.”

Implications for Telemedicine Providers:

The final rule will significantly impact telemedicine practices, particularly for providers managing patients with chronic pain, mental health conditions, and substance use disorders. Providers will need to adapt to new identity verification protocols, maintain robust documentation of telemedicine encounters, and comply with stricter limitations on controlled substance prescribing.

The rule also signals the DEA’s commitment to ongoing oversight, as it includes provisions for tracking and auditing telemedicine prescribing trends. This will require healthcare systems and telemedicine platforms to invest in compliance infrastructure to meet regulatory standards.

Implications for Telehealth and Telemental Health Providers:

• Enhanced Access to Treatment: These provisions facilitate greater access to essential treatments for individuals with OUD, especially those in remote or underserved areas, by allowing initial prescriptions via telemedicine.

• Compliance Requirements: Providers must ensure compliance with PDMP review mandates and collaborate with pharmacists to verify patient identities, thereby upholding patient safety and adhering to regulatory standards.

• Operational Adjustments: Telehealth providers should adjust their practices to incorporate these new requirements, including updating protocols for PDMP checks and patient identity verification processes.

• Future Considerations: While the extension through 2025 provides temporary continuity, providers should stay informed about potential legislative changes that may impact telemedicine practices beyond this period.

Special Registrations for Telemedicine and Limited State Telemedicine Registrations

The Drug Enforcement Administration (DEA) has released a proposed rule titled "Special Registrations for Telemedicine and Limited State Telemedicine Registrations," aiming to expand patient access to controlled substance medications via telemedicine while mitigating risks of diversion.

Key Provisions:

1. Establishment of Special Registration Framework:

   • The proposed rule introduces a framework for Special Registration, authorizing three types of Special Registration for practitioners engaged in the practice of telemedicine.

2. Heightened Prescription Requirements:

   • Practitioners with a Special Registration will be subject to enhanced prescription requirements to ensure the safe prescribing of controlled substances via telemedicine.

3. Enhanced Recordkeeping and Reporting:

   • The rule proposes stricter recordkeeping and reporting obligations for Special Registrants to monitor and prevent potential diversion of controlled substances.

Implications for Telehealth and Telemental Health Providers:

• Access Expansion: The proposed Special Registration aims to facilitate greater access to controlled substance medications for patients, particularly in underserved or remote areas, by allowing qualified practitioners to prescribe via telemedicine.

• Compliance Obligations: Providers seeking Special Registration must adhere to the heightened prescription, recordkeeping, and reporting standards set forth in the proposed rule, necessitating updates to current practices and systems.

• Public Comment Period: Stakeholders have the opportunity to submit comments on the proposed rule until 60 days after its publication in the Federal Register. Electronic comments can be submitted through the Federal eRulemaking Portal at http://www.regulations.gov by referencing "Docket No. DEA–407."

Telehealth and telemental health providers should review the proposed rule in detail to understand the potential changes and prepare for compliance. Engaging in the public comment process is also encouraged to provide feedback on the proposed regulations.

Continuity of Care via Telemedicine for Veterans Affairs Patients

The Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) have jointly issued a final rule titled "Continuity of Care via Telemedicine for Veterans Affairs Patients." This rule authorizes Department of Veterans Affairs (VA) practitioners to prescribe controlled substances via telemedicine to VA patients without a prior in-person medical evaluation, under specific conditions.

Key Provisions:

1. Authorization for Telemedicine Prescriptions:

   • VA practitioners, acting within the scope of their VA employment, are permitted to prescribe Schedule II-V controlled substances to VA patients via telemedicine without having conducted an in-person medical evaluation, provided that:

     • Another VA practitioner has previously conducted an in-person medical evaluation of the patient at any time.

2. Mandatory Review of Patient Records:

   • Before issuing a prescription via telemedicine, the prescribing VA practitioner must review:

     • The patient's VA electronic health record (EHR), including the internal prescription database.

     • The Prescription Drug Monitoring Program (PDMP) data for the state where the patient is located during the telemedicine encounter, if such a program exists.

3. Contingency for Unavailable Records:

   • If either the VA EHR or the state PDMP is unavailable or non-operational:

     • The practitioner may prescribe a controlled substance limited to a 7-day supply.

     • The practitioner must subsequently review both the VA EHR and the state PDMP data before issuing any further prescriptions via telemedicine.

4. States Without PDMPs:

   • In states lacking a PDMP:

     • The practitioner must review the VA EHR, including the internal prescription database, before issuing a prescription for a controlled substance exceeding a 7-day supply.

5. Exclusions:

   • This rule does not apply to:

     • Contracted practitioners located outside a VA facility or clinic providing care via the Community Care Network (CCN).

     • Practitioners conducting disability compensation evaluations.

Implications for Telehealth and Telemental Health Providers:

• Enhanced Access to Care: This rule facilitates continuity of care for VA patients by allowing authorized VA practitioners to prescribe necessary controlled substances via telemedicine, reducing the need for in-person visits.

• Compliance Requirements: VA practitioners must ensure thorough review of patient records, including VA EHRs and state PDMP data, before prescribing controlled substances via telemedicine to comply with the new regulations.

• Operational Adjustments: VA healthcare systems may need to update protocols and training to align with the new rule, ensuring that practitioners are aware of and adhere to the specific conditions outlined for telemedicine prescribing.

This final rule is scheduled to be published in the Federal Register on January 17, 2025, and will become effective 30 days after publication. VA practitioners and associated telehealth providers should review the full text of the rule to understand the detailed requirements and ensure compliance.