Health Law Advisor

On Friday, February 14, 2025, the Drug Enforcement Administration (“DEA”) and the U.S. Department of Health and Human Services (“HHS”) announced that the effective dates for two recently published final rules involving telemedicine prescribing of controlled substances – the final rule titled “Expansion of Buprenorphine Treatment via Telemedicine Encounter” and the final rule titled “Continuity of Care via Telemedicine for Veterans Affairs Patients” (collectively referred to herein as the “Buprenorphine and VA Telemedicine Prescribing Rules”) – are delayed from February 18, 2025, until at least March 21, 2025 (see our previous post on the Buprenorphine and VA Telemedicine Prescribing Rules).

The final rule delaying the effective dates of these final rules is scheduled for publication to the Federal Register on Wednesday, February 19, 2025.

The delays stem from the Presidential Memorandum titled “Regulatory Freeze Pending Review,” (the “Freeze Memo”) issued on January 20, 2025. The Freeze Memo orders all executive departments and agencies to “consider postponing” the effective dates of all rules published to the Federal Register that have not yet taken effect, such as the Buprenorphine and VA Telemedicine Prescribing Rules, until at least March 21, 2025 (sixty days from the issuance of the Freeze Memo), to allow review of any questions of fact, law, and/or policy raised by the rule, and to “consider opening” a comment period for stakeholders to comment on those questions. Accordingly, the DEA is also soliciting comments on: 1) the extension of the effective dates, 2) whether the effective dates should be further extended, and 3) questions of fact, law, and policy raised by these rules, for consideration by officials of the two agencies. Comments are due by February 28, 2025.

Remote prescribing via telemedicine continues to be a huge area of interest among prescribers and other health care providers.

After publishing a Notice of Proposed Rulemaking (“NPRM”) in March 2023 on the prescribing of controlled substances via telemedicine that was widely criticized for being far more restrictive than temporary waivers then in place under the COVID-19 public health emergency, the Drug Enforcement Administration (“DEA”) went back to the drawing board.

Additional time and a new year has brought renewed focus. Published January 17 in the Federal Register as one NPRM and two final rules (collectively referred to herein as the “DEA’s 2025 Rules”), the DEA’s 2025 Rules seek, as DEA indicates in its press release, to “focus[] on the patient to ensure telemedicine is accessible for medical care.”

On Friday, November 15, 2024, the Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) filed a Third Temporary Extension of the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (“Third Temporary Extension”), extending the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency (“PHE”) through December 31, 2025. The Third Temporary Extension is scheduled for publication in the Federal Register on November 19, 2024.

This means the DEA will continue to allow DEA registered practitioners (“Practitioners”) to prescribe controlled substances via telemedicine without having previously conducted an in-person patient examination. Likewise, and of particular interest to telemedicine providers that practice in multiple states, Practitioners may continue prescribing via telemedicine to patients physically located in any state in which the Practitioners are licensed to practice medicine, without needing to have a separate DEA registration in each such state, subject to compliance with state prescribing requirements.

As the dust from the public health emergency (PHE) continues to settle and the PHE-era flexibilities expire, telehealth providers are bracing themselves for the changes soon to come.

These providers will inevitably face certain legal and regulatory complexities as federal and state lawmakers and regulators consider adopting further temporary or permanent policy changes impacting telehealth. Federal-level changes—particularly the Drug Enforcement Administration’s (DEA’s) remote prescribing rulemaking—may further compound these complexities and trigger a wave of changes in laws, regulations, and policies at the state and board levels.

Telehealth providers should continue to monitor these developments, capitalize on current and upcoming telehealth opportunities, and make investments in compliance infrastructures to operate in accordance with applicable federal and state laws, regulations, and policies.

Since 2016, Epstein Becker Green has researched, compiled, and analyzed state-specific content relating to the regulatory requirements for professional mental/behavioral health practitioners and stakeholders seeking to provide telehealth-focused services. 

We are pleased to once again release our latest update to our Telemental Health Laws app, an extensive compilation of laws, policies, and other state guidance for practitioners supporting the mental/behavioral health practice disciplines.

Interest in and acceptance of telehealth services continues to grow. In 2023, a key focus by the states has been addressing questions about how to modify existing regulatory infrastructures sustaining the provision of telehealth services to support the continued use of these services in a post-public health emergency world.

However, modifications to telehealth services also increases the potential for fraudulent behavior and enforcement activity. Providers should continue to monitor developments in federal and state laws, regulations, and policies to capitalize on ...

On Friday, October 6, 2023, the Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) filed a Second Temporary Extension of the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (“Second Temporary Rule”), extending the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency (“PHE”) through December 31, 2024. The Second Temporary Rule is scheduled for publication in the Federal Register today (October 10, 2023) and scheduled to take effect on November ...

On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced proposed permanent rules around prescribing controlled substances via telemedicine that expand the circumstances under which practitioners can prescribe controlled substances without first conducting an in-person medical evaluation of the patient outside of the COVID-19 public health emergency (“PHE”). The proposed rules are more restrictive than the DEA emergency waivers under which providers conducted telemedicine prescribing for the last three years, but are less restrictive in comparison to the pre-PHE regulations applicable to telemedicine prescribing of controlled substances under the federal Controlled Substances Act (“CSA”).

Both the proposed rules related to telemedicine prescribing of Schedule III-V non-narcotic controlled substances, and the separate proposed rules related to telemedicine prescribing of buprenorphine, were published in the Federal Register on March 1, 2023. The public has been given until March 31, 2023 to review and provide comments regarding the proposed rules, which the DEA will consider before promulgating final regulations.

In the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. On February 14, 2023, the Utah Senate passed a bill that would repeal the State’s “Online Prescribing, Dispensing, and Facilitation Licensing Act” (“Online Prescribing Act”). Utah H.B. 152. The bill currently awaits Governor Spencer Cox’s signature and would take effect sixty (60) days after its signing.[1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306. While providers have been required under the Online Prescribing Act to obtain a comprehensive patient history and assessment prior to issuing a prescription, at present, this may be done via telehealth. Utah Code § 58-83-305. Once signed into law, the effect of H.B. 152 would be to make asynchronous telehealth-only prescribing unlawful in the state, with Utah’s law on the scope of telehealth practice amended to prohibit “diagnos[ing] a patient, provid[ing] treatment, or prescribe[ing] a prescription drug based solely on . . . an online questionnaire; []an email message; or []a patient-generated medical history. Utah H.B. 152, amending Utah Code § 26-60-103.