Telehealth Prescribing Policy Overview.  The Center for Connected Health Policy (CCHP) has developed the following video primer on telehealth prescribing policy:

 

The Ryan Haight Act and Telehealth Prescribing

  • Background:  The Ryan Haight Act of 2008 prohibits the delivery, distribution or dispensing of controlled substances without a valid prescription.  A prescription is considered valid only when issued for a legitimate medical purpose by:
    • a practitioner who has conducted at least one in-person medical evaluation of the patient; or
    • a covering practitioner (e.g., another authorized prescriber acting on behalf of the original provider).
  • Pre-COVID-19 Exceptions:  Before the COVID-19 pandemic, the Ryan Haight Act allowed a few exceptions to the in-person evaluation requirement, including:
    • Patients treated in a DEA-registered facility (e.g., hospital or clinic).
    • Patients seen in the presence of another DEA-registered practitioner.
    • Telemedicine consults conducted by a DEA-registered provider for:
      • Indian Health Service (IHS) if designated as an Internet Eligible Controlled Substances Provider by the DEA.
      • Veterans Health Administration (VHA) practitioner during a VHA-recognized medical emergency.
    • Declared Public Health Emergencies (PHEs) by the Secretary of the U.S. Department of Health and Human Services (HHS).
    • Practitioner who have obtained a special DEA registration for telemedicine or under other circumstances specified by future DEA regulations.

The mechanism for a DEA special registration for telemedicine was never established, despite Congress passing the SUPPORT for Patients and Communities Act in 2018 directing the DEA to promulgate final regulations for the registry.   In response to the lack of action by the DEA and given the worsening opioid overdose crisis, the Alliance for Connected Care convened more than 80 organizations, jointly signed a letter urging the DEA to move forward with the telemedicine special registration process required by federal law that will enable SAMHSA waivered clinicians, community mental health centers and addiction treatment facilities to prescribe medication assisted treatment (MAT) drugs to patients with OUD employing telemedicine technology. To read about the issue in more detail and view the letter, see the Alliance for Connected Care’s webpage on the issue.

  • The Public Health Emergency (PHE) and Temporary Telehealth Flexibilities.  The declaration of the COVID-19  Public Health Emergency (PHE) in March 2020 triggered one of the Ryan Haight Act exceptions, temporarily allowing for the expanded use of telemedicine in prescribing controlled substances for the duration of the PHE.
    • In May 2021, Senator Warner sent a letter to Attorney General Merrick Garland regarding the long-delayed regulations and expressed great concern for the delay.
    • In April 2022, Senators Portman and Whitehouse sent a letter to Administrator Anne Milgram of the U.S. Drug Enforcement Administration (DEA) and Secretary Xavier Becerra of the Department of Health and Human Services (HHS), urging the agencies to use their authority under the Ryan Haight Act to ensure Americans can continue to access important medication, such as Medication Assisted Therapies (MAT) for substance use disorder and other necessary drugs, via telehealth once the COVID-19 PHE ends..
    • On February 24, 2023 the DEA announced proposed rules for permanent telemedicine flexibilities.  While the proposed rule did include a few additional flexibilities, it did not include  a mechanisms for implementing a provider registry.  The Center for Connected Health Policy (CCHP) created this video about the proposed rules:
  • Post-PHE Policy Changes.  The PHE officially ended on May 11, 2023. 
    • At the beginning of May, the DEA filed a draft temporary rule with the OMB titled "Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications".  The proposed "temporary" rule was published in the Federal Register on May 9, 2023 and was developed jointly between the DEA and SAMHSA.  Highlights of the Proposed Temporary Rule:
      • More time is needed to review all the comments and to educate providers, patients and pharmacists about any upcoming changes.
      • The PHE flexibilities will be extended through November 11, 2023.
      • Any practitioner - patient telemedicine relationships established on/before November 11, 2023 will be permitted to continue under the PHE flexibilities through November 11, 2024.
    • On October 6, 2023, the DEA and HHS extended the current telemedicine flexibilities through December 31, 2024.
    • On November 11, 2024, the DEA and HHS extended the current telemedicine flexibilities through December 31, 2025

Proposed Rule for Special Registration for Telemedicine 

Rules for Prescribing Through Telehealth by Opioid Treatment Programs (OTPs)

  • Background:  During the COVID-19 PHE, SAMHSA (Substance Abuse and Mental Health Services Administration) provided an exemption allowing Opioid Treatment Programs (OTPs) to:
    • Conduct evaluations via audio-video or audio-only telehealth for patients receiving buprenorphine.
    • Skip the previously required in-person physical evaluation under certain conditions.
  • Final Rule: Expansion of Buprenorphine Treatment via Telemedicine Encounter (Implementation delayed until December 31, 2025 to allow further review)
    • DEA-registered providers may prescribe buprenorphine for treatment of opioid use disorder (OUD) via audio-only or audio-video telemedicine under these conditions:
      • Prior to issuing a prescription via telemedicine for a schedule III-V controlled substance approved by the Food and Drug Administration (FDA) for use in the treatment of opioid use disorder (OUD), must review the prescription drug monitoring program (PDMP) data of the state in which the patient is located when the telemedicine encounter occurs.
      • Annotate date and times of PDMP review or if  PDMP is unavailable or inaccessible, note review attempts at each seven-day prescription renewal until the six-month limit is reached.
      • The practitioner can issue prescriptions for up to 6 months (split amongst several prescriptions totaling six calendar months).  Additional prescriptions may be issued under other forms of telemedicine as authorized by the Controlled Substances Act (CSA) or after an in-person medical evaluation is conducted.
      • The pharmacist must verify the identity of the patient before filling prescription

Rules for Prescribing Through Telehealth to Maintain Continuity of Care for Veterans Affairs Patients

  • Background: The DEA issued a proposed rule in March 2023 that authorizes Department of Veterans Affairs practitioners acting within the scope of their VA employement to prescribe controlled substances via telemedicine to a VA patient with whom thay have not conducted an in-person medical evaluation, if another VA practitioner has, at any time, previously conducted an in-person medical evaluation of the VA patient.
  • Final Rule: Continuity of Care via Telemedicine for Veterans Affairs Patients (Implementation delayed until December 31, 2025 to allow further review)
    • VA pracititioners may prescribe controlled substances via telemedicine without an in-person evaluation if another VA provider has previously conducted an in-person evaluation
      • The DEA notes that this rule does not apply to contracted practitioners located outside a VA facility or clinic providing care via the community care network (CCN) or conducting disability compensation evaluations.
    • VA practitioners must:
      • Review both the patient’s VA electronic health record (EHR), which includes the internal VA prescription database, and the prescription drug monitoring program (PDMP) data for the state in which the VA patient is located at the time of the telemedicine encounter.
      • If the VA EHR or state PDMP are unavailable or inaccessible, the practitioner must limit the prescription to a 7-day supply and must later review both the patient’s VA EHR and the PDMP data for the state in which the patient is located at the time of the telemedicine encounter before continuing to prescribe controlled substances to the patient via telemedicine.  If no PDMP program exists for the state in which the VA patient is located, the provider must review the VA EHR prior to issuing a prescription for more than a 7-day supply.

State-Specific Prescribing Laws 

While federal laws and regulations dictate the general framework for telehealth prescribing, state laws may impose additional requirements. It's essential for providers to stay up to date on state-specific restrictions on controlled substance prescribing via telehealth, including licensing requirements for out of state telehealth providers and varying PDMP compliance regulations.