By Kaitlyn Snyder
On November 19, 2024, the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) issued a Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, extending the flexibilities through December 31, 2025.[1] The third—and supposedly final—temporary extension aims to give the DEA and HHS enough time to push through their three newest proposed rules, which were released on January 16, 2025.[2] The proposed rules govern buprenorphine treatment via telemedicine, the establishment of a special registration pathway to allow specialized providers to continue telemedicine prescription of controlled substances, and continuity of care via telemedicine for Veterans Affairs patients.[3]
Background
In 2022, nearly nine million prescriptions for controlled substances had been distributed for human treatment in North Carolina.[4] Controlled substances are medications that have been classified by their potential for abuse or dependency.[5] Controlled substances are divided into five schedules, with Schedule I including illicit drugs with extreme addiction risk, and Schedule V including drugs with lower potential for abuse, but “preparation containing limited quantities of certain narcotics,” like some cough medications.[6] Schedule II drugs include opioids and certain medications for treating ADD/ADHD, such as Ritalin and Adderall.[7] Schedule III drugs have a slightly lower potential for dependency, and include medications used in gender-affirming treatment, like testosterone, and opioid addiction, such as buprenorphine.[8] Schedule IV has a lower dependency risk, and includes medications for treating anxiety and other mental health disorders, such as Xanax, Valium, and Tramadol.[9]
In 2008, as a response to the increasing use of controlled substances illegally dispensed via telemedicine—a trend which greatly contributed to the opioid crisis, especially among adolescents[10]—Congress introduced the Ryan Haight Online Pharmacy Consumer Protection Act (Ryan Haight Act), which required a provider to conduct an in-person examination of a patient before prescribing any controlled substances.[11]
Effects of COVID-19 on Prescription Access
When COVID-19 spread through the United States in 2020, access to prescription medications was impaired, with a two percent drop in prescription dispensation.[12] In response, the DEA and HHS temporarily suspended the requirements for in-person examinations under the Ryan Haight Act, to allow patients to continue getting necessary diagnoses and prescriptions for a variety of conditions for the duration of the public health emergency (PHE).[13] After the announcement of the end of the PHE, effective May 11, 2023, the DEA announced a set of proposed rules for prescribing controlled substances via telemedicine, that would largely return to the requirements under the Ryan Haight Act, reinstituting the requirement for an in-person exam prior to prescription.[14]
The 2023 proposed rules received over 38,000 comments, mostly in opposition to the return to pre-COVID prescribing requirements, raising concerns about access to medication, especially for patients who may be immunocompromised or otherwise unable to see their provider in person to continue receiving medication.[15] The number of comments prompted the agencies to extend the flexibilities a second and third time to allow for the gathering of feedback and implementation of suggestions into a new set of proposed rules.[16]
The 2025 Special Registration Proposed Rule
The 2025 Proposed Rules take a more flexible approach to prescribing controlled substances via telemedicine. Specifically, the Special Registrations for Telemedicine and Limited State Telemedicine Registrations Proposed Rule would introduce three pathways for providers to continue prescribing controlled substances via telemedicine.[17] The Proposed Rule would limit controlled substance prescription via telemedicine to providers with one of three types of Special Registrations: (1) a Telemedicine Prescribing Registration, which would allow clinician practitioners to prescribe Schedule III-V controlled substances; (2) an Advanced Telemedicine Prescribing Registration, allowing specialized practitioners, such as psychiatrists or hospice care providers, to prescribe Schedule II-V controlled substances via telemedicine; and (3) a Telemedicine Platform Registration, which would authorize select telemedicine platforms to dispense Schedule II-V controlled substances.[18] The Proposed Rule has currently received approximately 3500 comments, and comments are due by March 18, 2025.[19]
Effect on North Carolina
With over nine million controlled substance prescriptions per year in North Carolina, a huge number of North Carolina patients and providers stand to be affected by the Proposed Rule.[20] While the Special Registration pathways may allow providers to continue prescribing via telemedicine, registration will take time; the Proposed Rule states that applications shall be approved after consideration of whether the applicant meets the eligibility factors and whether the registration is consistent with the public interest, without a specified timeline.[21] Meanwhile, many North Carolina patients may require a telemedicine prescription option, as effects from Hurricane Helene linger, after the destruction of over 70,000 homes and nearly 7,000 roads and bridges.[22] Thus, patients and providers in North Carolina and across the nation wait with bated breath to see if the third time (or rather, temporary extension), is the charm and whether the Proposed Rule will become final.
[1] 42 C.F.R. § 12 (2024).
[2] DEA Announces Three New Telemedicine Rules that Continue to Open Access to Telehealth Treatment while Protecting Patients, U.S. Drug Enf’t Admin. (Jan. 16, 2025), https://www.dea.gov/press-releases/2025/01/16/dea-announces-three-new-telemedicine-rules-continue-open-access.
[3] Id.
[4] 2023 Controlled Substances Reporting System Annual Report, N.C. Dep’t Health and Hum. Servs. (Jul. 19, 2023), https://www.ncdhhs.gov/ncgs-90-11375b-controlled-substances-reporting-system-1/download?attachment.
[5] Drug Scheduling, U.S. Drug Enf’t Admin, U.S. Drug Enf’t Admin, https://www.dea.gov/drug-information/drug-scheduling (last visited Feb. 28, 2025).
[6] Id.
[7] Id.
[8] Id.
[9] Id.
[10] 21 C.F.R. §§ 1300–1306 (2008).
[11] Pub. L. No. 110-425, 122 Stat. 4280 (2008).
[12] Kyle Grimslid, One Year In: COVID-19 Impact on Prescriptions, Pharmacists, & Providers, covermymeds (Apr. 22, 2021), https://insights.covermymeds.com/healthcare-industry/innovation/one-year-in-covid-19-impact-on-prescriptions-pharmacists-and-providers.
[13] Letter from William T. McDermott, Assistant Administrator, U.S. Drug Enf’t Admin. Diversion Control Div. (Mar. 25, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.
[14] Nathaniel M. Lacktman, DEA’s Proposed Rules on Telemedicine Controlled Substances Prescribing after the PHE Ends, Foley & Lardner LLP (Feb. 27, 2023), https://www.foley.com/insights/publications/2023/02/deas-telemedicine-controlled-substances-phe-ends/.
[15] Markia Miller & Nathaniel M. Lacktman, New DEA Rule Extends Controlled Substance Telemedicine Prescribing Flexibilities One More Year, Foley & Lardner LLP (Nov. 18, 2024), https://www.foley.com/insights/publications/2024/11/new-dea-rule-extends-controlled-substance-telemedicine-prescribing/.
[16] DEA and HHS Extend Telemedicine Flexibilities Through 2025, U.S. Drug Enf’t Admin. (Nov. 15, 2024), https://www.dea.gov/documents/2024/2024-11/2024-11-15/dea-and-hhs-extend-telemedicine-flexibilities-through-2025.
[17] 90 Fed. Reg. 6541 (proposed Jan. 17, 2025) (to be codified at 21 C.F.R. § 1300).
[18] Id.
[19] Id.
[20] N.C. Dep’t Health and Hum. Servs., supra note 4.
[21] 90 Fed. Reg. 6541 (proposed Jan. 17, 2025) (to be codified at 21 C.F.R. § 1300).
[22] Gov. Roy Cooper, Hurricane Helene Recovery, N.C. Off. of State Budget and Mgmt. (Dec. 13, 2024), https://www.osbm.nc.gov/hurricane-helene-dna/open.
