DEA Prescribing of Controlled Substances

Special registration to prescribe controlled substances through telemedicine was originally called for in the Ryan Haight Act of 2008.  The Ryan Haight Act amended the Controlled Substances Act to prohibit the delivery, distribution, or dispensing of a controlled substance by “means of the Internet” without first conducting an in-person exam.  The Act directed the U.S. Drug Enforcement Agency (DEA) to create a special registration for telemedicine with the goal of increasing patient’s access to practitioners who can prescribe controlled substances via telehealth in limited circumstances.  On April 6, 2009, when implementing the Ryan Haight Act (at 74 FR 15603) the DEA stated that the agency would issue a separate rule regarding the special registration for telemedicine. It has not yet done so.

Congress returned to the issue in the SUPPORT for Patients and Communities Act, signed into law on October 24, 2018, which included a provision requiring the Attorney General – in consultation with the Secretary of Health and Human Services – to within one year promulgate final regulations related to a Special Registration for Telemedicine. The DEA did not release the regulation in October 2019.

The Fall 2019 Unified Agenda of Regulatory and Deregulatory Actions announced the Special Registration to Engage in the Practice of Telemedicine proposed rulemaking for December, 2019. Another deadline that has now been missed.

While a prescription for a controlled substance issued by means of the Internet (including telemedicine) generally requires an in-person medical evaluation, the Controlled Substances Act contains certain exceptions to this requirement. One such exception occurs when the Secretary of Health and Human Services has declared a public health emergency. Traditionally, a prescribing practitioner who has previously conducted an in-person medical evaluation may issue a prescription for a controlled substance regardless of whether a public health emergency has been declared.

The Drug Enforcement Administration announced that as long as the Secretary’s designation of a public health emergency remains in effect, DEA -registered practitioners may issue prescriptions for controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met (as defined under Section 802(54)(D):

• The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice
• The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system.
• The practitioner is acting in accordance with applicable Federal and State law.

On March 23, Administrator Anne Milgram announced the Drug Enforcement Administration’s continued commitment to expanding access to medication-assisted treatment to help those suffering from substance use disorder. Notably, the DEA announced that it will soon make permanent regulations around this issue.

In spring 2022, the Special Registration to Engage in the Practice of Telemedicine moved to OMB review (the last step before publication in the federal register for public review).

• • The anticipated registration would enable a practitioner to deliver, distribute, dispense, or prescribe via telemedicine a controlled substance to a patient who has not been medically examined in-person by the prescribing practitioner.  For example, in the event of an opioid overdose, a patient might need a prescription for an opioid antagonist such as naloxone from a provider who has never examined the patient in-person prior to the telemedicine encounter.  The Act also expressly exempts certain practitioners from needing to obtain a special registration for telemedicine in each state where the entities and practitioners choose to practice.

On June 22, 2022, the White House ONDCP released the Telehealth and Substance Use Disorder Services in the Era of Covid-19: Review and Recommendations. The report outlines several recommendations to improve access to telehealth, including making permanent the regulatory relief granted during the Public Health Emergency which made it easier to access medications for Opioid Use Disorders.

On June 27, 2022, Dr. Rahul Gupta, Director of the Office of National Drug Control Policy (ONDCP) testified on the federal government’s response to the overdose and addiction crisis, including the Biden-Harris Administration’s 2022 National Drug Control Strategy before the House Committee on Oversight and Reform. In particular, he noted that the Administration will extend use of telehealth services for substance use disorder treatment. This hearing can be found on C-Span.

On August 16, 2022, Sen. Warner (D-VA) sent a letter to the DEA for more details on the pending regulation. Sen. Warner posed a series of questions to ensure there is a plan to ensure continuity of care for patients being prescribed controlled substances via telemedicine after the end of the PHE.

On August 31, 2022, the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and the Centers for Medicare & Medicaid Services (CMS) published a collaborative study, which found that Medicare beneficiaries and providers used the COVID-19 flexibilities related to telehealth services during the COVID-19 pandemic and that these services were associated with positive impacts on patient outcomes such as medicated opioid use disorder (MOUD) treatment receipt, retention, and risk for medically treated overdose.

On December 20, 2022, the FY2023 Omnibus Appropriations bill, House and Senate Appropriators directs the DEA to promulgate final regulations specifying the circumstances in which a Special Registration for telemedicine may be issued and the procedure for obtaining the registration.

On January 4, 2023, the Fall Unified Agenda and Regulatory Plan, which provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions, was released. The Department of Justice’s agenda denotes the release of a notice of proposed rulemaking (NPRM) for the Special Registration to Engage in the Practice of Telemedicine in January 2023.

On Friday night, February 24, 2023, the DEA released two notice of proposed rulemaking on telemedicine.

• Telemedicine Prescribing of Controlled Substances
  • Alliance Summary
• Buprenorphine via Telemedicine
  • Summary

On March 20, 2023, Foley & Lardner released a white paper analysis, stating that the proposed rule does not meet statutory requirements for a telemedicine special registration process enabling practitioners to prescribe controlled substances via telemedicine without a prior, in-person medical evaluation.

Over 38,000 Americans provided comments. See a snapshot of the comments here.

After receiving over 38,000 comments, the DEA jointly with the Substance Abuse and Mental Health Services Administration (SAMHSA), issued a temporary rule, which extends the telemedicine flexibilities adopted during the COVID-19 public health emergency (PHE). The goal of this temporary rule is to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as allow adequate time for providers to come into compliance with any new standards or safeguards that DEA and/or SAMHSA promulgate in one or more final rules later this year. The temporary rule will:

• Maintain the full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE will remain in place through November 11, 2023, provided certain conditions are met.
• Additionally, for any practitioner-patient telemedicine relationships that have been or will be established on or before November 11, 2023, the full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE will continue to be permitted via a one-year grace period through November 11, 2024. In other words, if a patient and a practitioner have established a telemedicine relationship on or before November 11, 2023, the same telemedicine flexibilities that have governed the relationship to that point are permitted until November 11, 2024.

DEA and HHS released a second temporary rule which extended the pandemic flexibilities from November 11, 2024 to December 31, 2024.

DEA and HHS released a joint statement, noting that the extension would allow the agencies time to consider revisions to the proposed rules.

The Office of Management and Budget (OMB) released its spring regulatory agenda, which lists anticipated rulemaking from federal agencies over the next year or so. The Department of Justice (DOJ) listed the DEA telemedicine final rule as expected for December 2023.

On June 13, 2024, the Drug Enforcement Administration (DEA) Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation has started the Office of Management and Budget (OMB) review, beginning the critical step before rules are released.

In late August, it was widely reported that the Drug Enforcement Administration (DEA) planned to release an unworkable regulation without a clear path to maintaining patient access.

The Alliance for Connected Care quickly gathered hundreds of stakeholders for an emergency advocacy meeting regarding the news.

On September 10, more than 350 organizations sent letters to Congress and White House leaders, requesting them to intervene to ensure ongoing access to virtual prescribing for patients and providers of certain controlled substances.

On October 11, Sens. Whitehouse (D-RI), Murkowski (R-AK), Warner (D-VA) and Blackburn (R-TN) led 11 bipartisan senators in a letter to the White House, urging them to extend the current flexibilities. Reps. Matsui (D-CA) and Carter (R-GA) led 18 bipartisan colleagues in a letter to the DEA, urging it to extend current flexibilities.

On November 15, 2024, DEA and HHS released a one-year extension of current telemedicine flexibilities through December 31, 2025.

This action followed a large stakeholder effort led by the Alliance for Connected Care as well as congressional leaders from the Senate and House.

To the Alliance’s understanding, the permanent regulation is still progressing.