The Center for Connected Health Policy (CCHP) has created this video primer on telehealth prescribing policy:

 

The Ryan Haight Act and Prescribing of Controlled Substances

  • Historical Background:  Under the Ryan Haight Act of 2008, controlled substances may not be delivered, distributed, or dispensed without a valid prescription. A valid prescription must be issued for a legitimate medical purpose by 1) a practitioner who has conducted at least one in-person medical evaluation of the patient; or 2) a covering practitioner (e.g., another provider authorized to prescribe on behalf of the original prescriber).

Before the COVID-19 pandemic and the declaration of the Public Health Emergency (PHE), the Ryan Haight Act allowed limited 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 the Indian Health Service (IHS) and designated as an Internet Eligible Controlled Substances Provider by the DEA.
    • Telemedicine consults conducted by a Veterans Health Administration (VHA) practitioner during a VHA-recognized medical emergency.
    • During a Public Health Emergency (PHE) declared by the Secretary of the U.S. Department of Health and Human Services (HHS).
    • If the practitioner has obtained a DEA special registration for telemedicine or under other circumstances specified by future DEA regulations.

The DEA dragged its heels around the creation of a special registration for telemedicine.  In 2018, Congress passed the SUPPORT for Patients and Communities Act as part of an effort to combat the opioid epidemic. The Act directed the DEA to promulgate final regulations for the registry that would allow providers to prescribe controlled substances through telemedicine under certain circumstances. The DEA officially missed its deadline, set at one year from the passing of the Act on October 24, 2019.

  • Impact of the Public Health Emergency (PHE).  The declaration of a Public Health Emergency (PHE) in March 2020 triggered an allowance in federal law that temporarily allows for the expanded use of telemedicine in prescribing controlled substances for the duration of the PHE.
  • What Happens When the PHE Ends?  The allowances made for the PHE were set to expire at the end of the PHE (officially announced to end on May 11, 2023).  However, the DEA has issued a temporary extension (read on to the very bottom for the new timeline)!
    • 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, who 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.
    • 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) has created this video about the proposed rules:

A 30-day public comment period about the proposed rule recently ended and comments were many!  Here is a small sampling of the types of comments that were submitted:

The DEA received a record 38,369 public comments.  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..

Proposed Rule for Special Registration for Telemedicine and Limited State Telemedicine Registrations

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

  • Historical Background: During the Public Health Emergency (PHE), the Substance Abuse and Mental Health Services Administration (SAMHSA) created a specific exemption for Opioid Treatment Programs (OTPs) from having to conduct an in-person physical evaluation of patients who were being treated with buprenorphine if an OTP physician, primary care physician or authorized healthcare professional under the supervision of the program physician determined that such an evaluation could take place via audio-visual or audio-only telehealth. SAMHSA’s flexibility was extended for one year after the end of the PHE (to May 2024) or until a final rule was published.  On January 31, 2024, the Department of Health and Human Services (HHS) finalized rules for the prescribing of buprenorphine through the use of telehealth.
  • Final Rule: Expansion of Buprenorphine Treatment via Telemedicine Encounter.  The limitations and requirements within the final rule do not apply to provider-patient relationships where a prior in-person medical evaluation has occurred.  In summary, under the final rule (effective February 18, 2025), DEA-registered providers are authorized to prescribe buprenorphine for treatment of opioid use disorder (OUD) via audio-only or audio-video telemedicine as follows: :
    • A DEA-registered practitioner, 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.
      • The provider will need to annotate date and times of PDMP review. If the PDMP is unavailable or inaccessible, review attempts should also be noted while the provider can continue to prescribe renewable seven-day prescriptions until the six-month limit is reached, and while continuing to attempt to review the PDMP every seven days.
    • The practitioner is authorized to prescribe up to an initial six-month supply (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 prior to filling the prescription

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

  • Historical 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:  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.  In summary, under the final rule (effective February 18, 2025),  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 subject to certain conditions.  These conditions include:
    • Reviewing 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 state has such a program).
    • 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 Laws for Prescribing Controlled Substances

While federal laws and DEA regulations dictate how telehealth may be used for prescribing controlled substances, state laws also impose additional requirements. State policies vary, so practitioners must stay informed about specific prescribing laws in their state.