On January 16, 2025, the U.S. Drug Enforcement Administration (DEA) announced three new rules to make permanent some temporary telemedicine flexibilities established during the COVID-19 public health emergency:
1. Prescribing Schedule III-V Controlled Substances For The Treatment Of Opioid Use Disorder Via Telemedicine
Effective March 21, 2025, DEA-registered healthcare providers can prescribe certain addiction treatment medications through virtual visits, including phone calls. This applies to FDA-approved medications that are classified as Schedule III-V controlled substances and are specifically used to treat opioid addiction.
The new rule permits providers to prescribe an initial six-month supply of medication (split across multiple prescriptions) via telemedicine. After six months, practitioners can continue prescribing either through:
- An in-person medical evaluation; or
- Other forms of authorized telemedicine.
As a requirement of this regulation, practitioners must:
- Review state prescription drug monitoring program (PDMP) data before prescribing
- Document date and time of PDMP review in patient records
- Be properly registered/authorized to prescribe controlled substances
Pharmacists also have an obligation: Pharmacists must verify patient identity before filling prescriptions using government ID or other acceptable identification.
Current practitioner-patient relationships with prior in-person evaluations are not affected by this new regulation.
This rule was initially scheduled to go into effect February 18, 2025, but was delayed by the Presidential Memorandum titled “Regulatory Freeze Pending Review,” issued on January 20, 2025.
2. Special Registrations for Providers and Telehealth Companies
The DEA proposed a rule would create three separate “special registrations” to expand patient access to controlled substance medications via telemedicine while mitigating the risk of medications being diverted to illegal drug markets.
The three DEA-proposed registrations are:
- Telemedicine Prescribing Registration. This proposed rule would establish a registration process to authorize registered physicians and mid-level practitionersto prescribe Schedule III-V controlled substances via telemedicine.
- Advanced Telemedicine Prescribing Registration authorizing board-certified psychiatrists, hospice care physicians, physicians rendering treatment at long term care facilities, neurologists, and pediatricians to prescribe Schedule II-V controlled substances via telemedicine.
- Telemedicine Platform Registration requiring direct-to-consumer online telemedicine platforms that facilitate connections between patients and medical providers for the prescription of controlled medications to register with the DEA.
These rules would only apply where the prescribing practitioner intends to prescribe controlled substances and has never conducted an in-person medical evaluation of the patient.
Important requirements of the proposed rule include:
- Electronic prescribing of controlled substances (EPCS) would be mandatory for prescriptions issued under a special registration.
- Practitioners must verify patient identity using a state or federal government-issued photo identification.
- Before prescribing, conduct a nationwide Prescription Drug Monitoring Program (PDMP) check of all 50 states and any U.S. district or territory that maintains its own PDMP. This nationwide PDMP check requirement would be delayed for 3 years. In the interim, the practitioner would be required to conduct a PDMP check in the state where the patient is located, where the practitioneris located, and in each state/territory that has PDMP reciprocity agreements with the state(s) in which the patient and/or practitioner are located.
- Audio-video communication would be required (with limited exceptions for certain opioid-use disorder treatment).
- Demonstration that the practitioner has a legitimate need for special registration
To apply for these special registrations, physicians, clinicians, and platform providers would be required to submit an application form and pay a registration fee every three years. This proposed rulemaking also provides for heightened prescription, recordkeeping, and reporting requirements.
The proposed rule may not provide the flexibility that many practitioners were hoping for. Under the proposed rule, a physician may apply for a special registration to prescribe schedule III-V controlled substances without an in-person evaluation when the physician anticipates treating patients for whom in-person medical evaluations impose significant burdens.
The DEA provided the following examples of burdens that prevent patients from attending in-person medical evaluations:
- Severe weather conditions;
- Living in a remote or distant area; or
- Having a communicable disease that makes in-person appointments difficult or even unadvisable.
These requirements mean that most patients seeking controlled substances through telemedicine may still require an in-person evaluation.
3. Continuity of Care via Telemedicine for Veterans Affairs Patients
The DEA finalized a rule, in consultation with the U.S. Department of Veterans Affairs (VA), that authorizes VA practitioners, acting within the scope of their VA employment, to prescribe controlled substances via telemedicine to a VA patient with whom they have not conducted an in-person medical evaluation, if another VA practitioner has previously conducted an in-person medical evaluation with the VA patient.
Before prescribing any Schedule II-V controlled substances through telemedicine, the VA practitioner must:
- Review the patient's VA electronic health record (EHR), including the internal prescription database; and
- Check the PDMP data in the state where the VA patient is physically located during the telemedicine visit (if that state maintains a PDMP).
This rule was initially scheduled to go into effect February 18, 2025, but was delayed by the Presidential Memorandum titled “Regulatory Freeze Pending Review,” issued on January 20, 2025.
The effective date was delayed to December 31, 2025, to address public comments and review “any questions of fact, law, and policy that the rules may raise.”
Temporary Telemedicine Flexibilities Extended Through 2025
On November 15, 2024, the DEA, jointly with the U.S. Department of Health and Human Services, published the third temporary extension of certain exceptions to existing DEA regulations. These temporary flexibilities were first granted in March 2020 as a result of the COVID-19 public health emergency. They have been extended as a bridge measure to maintain access to care for telehealth patients while the DEA finalizes and implements a new set of regulations, including the rules introduced above.
The following telemedicine flexibilities are extended through December 31, 2025: DEA-registered practitioners can prescribe Schedule II-V controlled substances via telemedicine, and no in-person medical evaluation is required if specific conditions are met, including:
- Prescriptions must be for legitimate medical purposes within normal professional practice.
- Must use interactive telecommunications system (as defined in 42 CFR 410.78(a)(3)).
- Practitioners must either have proper DEA registration for the controlled substance being prescribed or be exempt from registration requirements under federal law.
- Must comply with all other prescription requirements under 21 CFR part 1306.
This extension is a temporary measure to maintain patient access to care while the new permanent telemedicine regulations, including those discussed above, are finalized and implemented.
Learn more about telehealth and telemedicine compliance in Texas.