The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have announced a delay in the effective date for the recently issued final rules regarding the telemedicine prescribing of buprenorphine and telemedicine for Veterans Affairs Patients (which are further detailed below). Originally scheduled to become effective February 18, the rules will now take effect on March 21, 2025. This decision aligns with the White House memorandum issued on January 20, which called for “A Regulatory Freeze Pending Review” to allow agencies further review of any fact, law, and policy considerations prior to proposing, issuing, or finalizing any regulatory activities. In particular, the DEA/HHS announcement cites the third paragraph of the Freeze Memo, which ordered agencies to consider postponing the effective dates for any recently published rules that have yet to take effect. The DEA and HHS have also confirmed that the waiver provisions established in the third extension of telemedicine flexibilities for prescribing controlled substances will remain in effect through December 31, 2025, ensuring that in-person visit requirements continue to be waived for the remainder of 2025. Public comments are being solicited on the postponement and whether the effective dates of the final rules should be extended beyond March 21. The notice also requests any comments related to potential issues of fact, law, or policy raised by the rules that should be considered. The comment period deadline is February 28. Below is a summary of the contents of the buprenorphine rule and Veterans Affairs rule, as well as a recap of the recently proposed Telemedicine Special Registration rule.  These rules were also summarized in a previous newsletter by the Center for Connected Health Policy (CCHP) when they were initially issued in January 2025. BUPRENORPHINE RULE Existing permanent law (which was active prior to the telehealth waivers going into effect) authorizes telemedicine prescribing only under specified circumstances when no in-person visit has occurred, with few exceptions. The new final rule, titled Expansion of Buprenorphine Treatment via Telemedicine Encounter, creates an additional avenue for practitioners to meet the requirements of the Controlled Substances Act when an in-person visit has not been conducted.  The key provisions addressing audio-only and audio-video telemedicine in the final buprenorphine rule include: – Prescription Drug Monitoring Program (PDMP) Review: Before issuing a telemedicine prescription for a Schedule III-V controlled substance approved for opioid use disorder (OUD) treatment, the provider must review the PDMP data for the patient’s state. – Initial Prescription Limitations: Providers may prescribe an initial six-month supply (split among several prescriptions) without an in-person evaluation. Additional prescriptions require an in-person evaluation or must comply with other forms of telemedicine authorized under the Controlled Substances Act (CSA). – Pharmacist Identity Verification: Pharmacists must verify patient identity before filling prescriptions. Notably, the rule does not impact provider-patient relationships where a prior in-person medical evaluation has occurred. VETERANS AFFAIRS RULE This final rule, titled Continuity of Care via Telemedicine for Veterans Affairs Patients, authorizes Department of Veterans Affairs (VA) practitioners to prescribe controlled substances via telemedicine to VA patients without a prior in-person evaluation, provided another VA practitioner has conducted an in-person evaluation at any time. Conditions include: – Reviewing both the VA electronic health record (EHR) and the state PDMP where the patient is located. – If the VA EHR or PDMP is unavailable, prescriptions must be limited to a seven-day supply until the provider can review the required data. – This rule does not apply to non-VA-contracted practitioners or those providing care via the community care network (CCN). The DEA has indicated that while this rule is specific to VA practitioners due to their closed-system operation, it may consider extending similar authorities to non-VA providers in the future. Meanwhile, as noted previously, the DEA’s exemption from in-person requirements remains in place through December 31, 2025. SPECIAL REGISTRATION RULE (Proposed Rule) The DEA has also proposed a special registration rule to establish a framework for telemedicine prescribing of controlled substances. This rule introduces three types of special registrations: 1. Telemedicine Prescribing Registration: Allows qualified practitioners to prescribe Schedule III-V controlled substances. 2. Advanced Telemedicine Prescribing Registration: Allows specialized practitioners (e.g., psychiatrists, hospice physicians) to prescribe Schedule II-V controlled substances. 3. Telemedicine Platform Registration: Allows approved online telemedicine platforms to dispense Schedule II-V controlled substances through authorized providers. Registrants under this rule must use both audio and video components for telemedicine encounters and obtain a State Telemedicine Registration for each state in which they treat patients unless exempted. Prescriptions must be issued electronically through Electronic Prescribing for Controlled Substances (EPCS) after verifying patient identity. Additionally, providers must conduct a nationwide PDMP check, though this requirement will have a delayed implementation timeline of three years. Until then, PDMP checks will be required for the patient’s state, the provider’s state, and any states with reciprocity agreements. For Schedule II controlled substances, further restrictions apply, such as requiring the prescribing practitioner to be in the same state as the patient and limiting the proportion of Schedule II prescriptions issued via special registration telemedicine encounters to 50% of the practitioner’s total Schedule II prescriptions in a calendar month.  Finally, the proposed rule establishes specific regulations for online telemedicine platforms that facilitate prescribing. It defines “covered online telemedicine platforms” based on criteria such as promoting or advertising-controlled substance prescriptions, financial incentives tied to prescribing volume, exerting control over clinicians’ prescribing decisions, and controlling patient medical records or prescriptions. Hospitals, clinics, insurers, and local in-person medical practices are exempt from these platform classifications. The proposed Special Registration Rule was published in the Federal Register on January 17, 2025, and public comments will be accepted through March 18, 2025. Again, the general DEA in-person requirement waiver remains in effect until the end of 2025. However, it is possible that state professional requirements around prescribing may also apply in the meantime – please utilize CCHP’s Policy Finder tool to search by state and topic for additional information. For full details on all the recent federal prescribing rules, refer to the following DEA regulations: – Effective Date Delay, Comments due February 28:  Buprenorphine & VA Rule Delay Announcement and Comment Request – Final Rule (New effective date March 21): Expansion of Buprenorphine Treatment via Telemedicine Encounter – Final Rule (New effective date March 21): Continuity of Care via Telemedicine for Veterans Affairs Patients – Proposed Rule, Comments Due March 18, 2025: Special Registrations for Telemedicine and Limited State Telemedicine Registrations For more background on past DEA attempts to adopt permanent telehealth prescribing regulations, please access: – CCHP’s September 2024 Newsletter Article: DEA Prepares New Regulations for Telemedicine Prescribing of Controlled Substances – CCHP’s July 2024 Newsletter Article: Regulatory Crossroads: Past, Present and Potential Future – Telemedicine Controlled Substance Prescribing Amid Fraud Concerns  – CCHP Resource: Evolution of Telehealth Controlled Substance Prescribing Timeline.

Source: Center for Connected Health Policy, personal communication, February 25 2025