[Federal Register Volume 90, Number 247 (Wednesday, December 31, 2025)]
[Rules and Regulations]
[Pages 61301-61306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-24123]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1307
[Docket No. DEA-407]
RIN 1117-AB40, 1117-AB78, and 1117-ZA07
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 12
Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities
for Prescription of Controlled Medications
AGENCY: Drug Enforcement Administration, Department of Justice;
Substance Abuse and Mental Health Services Administration, Department
of Health and Human Services.
ACTION: Temporary rule.
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SUMMARY: The Drug Enforcement Administration (DEA) jointly with the
Department of Health and Human Services (HHS) is issuing a fourth
extension of telemedicine flexibilities for the prescribing of
controlled medications through December 31, 2026.
DATES: This rule is effective January 1, 2026 through December 31,
2026.
FOR FURTHER INFORMATION CONTACT: Heather Achbach, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, VA 22152, Telephone: (571) 776-3882.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Ryan Haight Online Pharmacy Consumer Protection Act of
2008 (the Ryan Haight Act), a prescribing practitioner--subject to
certain exceptions--may remotely prescribe controlled substances to a
patient (colloquially referred to as
[[Page 61302]]
``telemedicine'') \1\ only after conducting at least one in-person
medical evaluation of that patient in the course of their practitioner-
patient relationship. Once a practitioner has conducted at least one
in-person medical evaluation of a particular patient, the specific
requirements of the Ryan Haight Act related to remote prescribing of
controlled substances no longer apply to that specific practitioner-
patient relationship. This permits the practitioner to remotely
prescribe controlled substances to that patient indefinitely,
regardless of how much time has passed since the initial in-person
medical evaluation or whether that evaluation was for a separate
medical concern, so long as such prescriptions are issued for a
legitimate medical purpose while acting in the usual course of
professional practice and in compliance with other relevant federal and
state statutes and regulations. Regardless of whether a practitioner-
patient relationship is subject to the specific remote prescribing
rules of the Ryan Haight Act, however, the practitioner must still
comply with all other applicable DEA regulations.
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\1\ It is important to distinguish the colloquial understanding
of ``telemedicine'' in this context from its statutory definition in
the Ryan Haight Act, 21 U.S.C. 802(54). The statutory term refers to
the remote practice of medicine, via certain telecommunication
systems, where a practitioner (other than a pharmacist) prescribes a
controlled substance to a patient whom the practitioner has never
conducted an in-person medical evaluation. This is permissible only
under one of seven specific, congressionally approved circumstances
as detailed in 21 U.S.C. 802(54)(A)-(G).
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In response to the COVID-19 Public Health Emergency (COVID-19 PHE),
as declared by the Secretary of HHS (the ``Secretary'') on January 31,
2020, pursuant to the authority under section 319 of the Public Health
Service Act (42 U.S.C. 247), DEA granted temporary exceptions to the
remote prescribing requirements of the Ryan Haight Act and DEA's
implementing regulations under the authority granted by 21 U.S.C.
802(54)(D). These exceptions, often referred to as the ``telemedicine
flexibilities,'' authorized practitioners to prescribe Schedule II-V
controlled medications via audio-video telemedicine encounters,
including Schedule III-V narcotic controlled medications approved by
the Food and Drug Administration (FDA) for maintenance and withdrawal
management treatment of opioid use disorder via audio-only telemedicine
encounters, provided that such prescriptions otherwise comply with the
requirements outlined in DEA guidance documents, DEA regulations, and
applicable Federal and State law. DEA granted those temporary
exceptions to the Ryan Haight Act and DEA's implementing regulations
via two letters published in March 2020:
A March 25, 2020 ``Dear Registrant'' letter signed by
William T. McDermott, DEA's then-Assistant Administrator, Diversion
Control Division (the McDermott Letter); \2\ and
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\2\ William T. McDermott, DEA Dear Registrant letter, Drug
Enforcement Administration (March 25, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.
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A March 31, 2020 ``Dear Registrant'' letter signed by
Thomas W. Prevoznik, DEA's then-Deputy Assistant Administrator,
Diversion Control Division (the Prevoznik Letter).\3\
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\3\ Thomas W. Prevoznik, DEA Dear Registrant letter, Drug
Enforcement Administration (March 31, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Fina
l)%20+Esign.pdf.
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The 2023 Telemedicine NPRMs
On March 1, 2023, DEA, jointly with HHS, promulgated two notices of
proposed rulemaking (NPRMs) in the Federal Register--``Telemedicine
Prescribing of Controlled Substances When the Practitioner and the
Patient Have Not Had a Prior In-Person Medical Evaluation'' \4\ (the
``General Telemedicine NPRM'') and ``Expansion of Induction of
Buprenorphine via Telemedicine Encounter'' \5\ (the ``Buprenorphine
NPRM'')--which proposed to expand patient access to prescriptions for
controlled medications via telemedicine encounters relative to the pre-
COVID-19 Public Health Emergency (PHE) landscape. The purpose of the
two proposed rules was to make permanent some of the telemedicine
flexibilities established during the COVID-19 PHE in order to
facilitate patient access to controlled medications via telemedicine
when consistent with public health and safety, while maintaining
effective controls against diversion. The comment period for these two
NPRMs closed on March 31, 2023. Those NPRMs generated a total of 38,369
public comments--35,454 comments on the General Telemedicine NPRM and
2,915 comments on the Buprenorphine NPRM. Many of those comments
requested changes of varying degrees.
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\4\ 88 FR 12875 (Mar. 1, 2023).
\5\ 88 FR 12890 (Mar. 1, 2023).
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The First Temporary Rule
On May 10, 2023, DEA, jointly with HHS (with the Substance Abuse
and Mental Health Services Administration (SAMHSA) acting on behalf of
HHS), issued the first temporary extension (the ``First Temporary
Rule''), which extended the full set of the telemedicine flexibilities
that had been in place under the COVID-19 PHE, through November 11,
2023.\6\ The First Temporary Rule also provided a one-year grace
period, through November 11, 2024, to any practitioner-patient
relationships that had been or would be established on or before
November 11, 2023. In other words, under the First Temporary Rule, if a
patient and a practitioner had remotely established a practitioner-
patient relationship by or before November 11, 2023, the same
telemedicine flexibilities that had governed the relationship to that
point would continue to apply through November 11, 2024.
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\6\ Temporary Extension of COVID-19 Telemedicine Flexibilities
for Prescription of Controlled Medications, 88 FR 30037 (May 10,
2023).
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The Second Temporary Rule
On August 7, 2023, DEA announced that it would host Telemedicine
Listening Sessions on September 12 and 13, 2023, for the purpose of
obtaining additional input on the practice of telemedicine and
potential safeguards that could effectively prevent and detect
diversion of controlled substances prescribed via telemedicine. On
October 10, 2023, DEA, jointly with HHS, issued a second temporary
extension (the ``Second Temporary Rule'') again extending the full set
of telemedicine flexibilities through December 31, 2024.\7\ The Second
Temporary Rule, like the preceding extension, authorized all DEA-
registered practitioners to remotely prescribe Schedules II-V
controlled substances through December 31, 2024, without an in-person
medical evaluation. This rule superseded the grace period from the
First Temporary Rule by applying the telemedicine flexibilities to all
practitioner-patient relationships until the end of 2024, not just
those established by November 11, 2023.
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\7\ Second Temporary Extension of COVID-19 Telemedicine
Flexibilities for Prescription of Controlled Medications, 88 FR
69879 (October 10, 2023).
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Third Temporary Rule
On November 19, 2024, DEA, jointly with SAMHSA/HHS, issued a third
temporary extension (the ``Third Temporary Rule'') extending the full
set of telemedicine flexibilities through December 31, 2025.\8\ Like
the two preceding extensions, the Third
[[Page 61303]]
Temporary Rule authorized all DEA-registered practitioners to remotely
prescribe Schedules II-V controlled substances through December 31,
2025, so as to prevent lapses in patient care by allowing DEA more time
to develop permanent regulations for prescribing controlled substances
via telemedicine. The extension ensured and provided time for
stakeholders to prepare for new rules.
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\8\ Third Temporary Extension of COVID-19 Telemedicine
Flexibilities for Prescription of Controlled Medications, 89 FR
91253 (November 19, 2024).
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The Special Registration for Telemedicine NPRM
On January 17, 2025, DEA published the ``Special Registrations for
Telemedicine and Limited State Telemedicine Registrations'' Notice of
Proposed Rulemaking (NPRM), which proposed a framework for a Special
Registration for Telemedicine, pursuant to 21 U.S.C. 802(54)(E),
authorizing physicians and mid-level practitioners with the Special
Registration to prescribe controlled substances via audio-video
telemedicine (and in limited instances, audio-only telemedicine)
without having ever conducted an in-person medical evaluation of the
patient, provided they adhere to the proposed prescription,
recordkeeping, and reporting requirements. The NPRM further proposed
the registration of certain direct-to-consumer (DTC) telemedicine
platforms that function as intermediaries and are integral to the
practitioner-patient relationship.\9\ In response to the Special
Registration NPRM, DEA received over 6,475 comments.
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\9\ See Special Registrations for Telemedicine and Limited State
Telemedicine Registrations, 90 FR 6541 (January 17, 2025).
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Fourth Temporary Rule
With the December 31, 2025 expiration date of the Third Temporary
Rule quickly approaching, DEA, jointly with HHS, is now issuing a
fourth temporary extension (``Fourth Temporary Rule'') to prevent what
has been commonly referred to as the ``telemedicine cliff:'' the
reinstatement of the pre-pandemic restrictions imposed by the CSA,
which could potentially and abruptly limit patients' access to care
until promulgation of a final set of regulations. Collaterally, the
extension will provide time for DEA to promulgate a final set of
regulations, to ensure a smooth transition for patients and providers
that have come to rely on the availability of telemedicine to prescribe
controlled substances to patients for whom they have never had an in-
person medical evaluation, and allow sufficient time for providers to
come into compliance with any new DEA registration, recordkeeping, or
security requirements eventually adopted in a final set of regulations.
II. Legal Authority
The Ryan Haight Act amended the Controlled Substances Act (CSA) to
generally require that the dispensing of controlled substances by means
of the internet is predicated on a valid prescription involving at
least one in-person medical evaluation.\10\ At the same time, it also
established seven excepted categories of telemedicine pursuant to which
a practitioner may prescribe controlled substances for a patient
despite having never evaluated that patient in-person, provided that,
among other things, such practice is in accordance with applicable
Federal and State laws.\11\ One of these categories authorizes the
Attorney General and the Secretary to jointly promulgate rules that
would allow practitioners to prescribe medications for patients via
telemedicine without having had an in-person medical evaluation when
such telemedicine practice is in accordance with applicable Federal and
State laws, uses an approved telecommunications system, and is
``conducted under . . . circumstances that the[y have] . . . determined
to be consistent with effective controls against diversion and
otherwise consistent with the public health and safety.'' \12\ Pursuant
to this authority, DEA, jointly with HHS, is hereby promulgating this
Fourth Temporary Rule specifying certain circumstances under which
practitioners may prescribe controlled substances, for the time period
described above, to patients whom the practitioner has never evaluated
in person.
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\10\ 21 U.S.C. 829(e).
\11\ 21 U.S.C. 802(54)(A)-(G). The Attorney General has
delegated his rulemaking authority under this provision to the
Administrator of DEA via 28 CFR 0.100. The Secretary delegated his
rulemaking authority under 21 U.S.C. 802(54)(G) to the Assistant
Secretary for Mental Health and Substance Use within the Substance
Abuse and Mental Health Services Administration on May 4, 2023.
\12\ 21 U.S.C. 802(54)(G).
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This Fourth Temporary Rule, like the first three Temporary Rules,
covers the portions of the March 2023 NPRMs related to extensions of
the telemedicine flexibilities in place during the COVID-19 PHE, and it
extends, through December 31, 2026, the telemedicine flexibilities that
have been in place since March 2020 for prescribing controlled
substances via the practice of telemedicine. Due to the impending
expiration of the flexibilities provided in the Third Temporary Rule,
DEA, jointly with HHS, has elected to again extend those flexibilities
to maintain access to care during a limited window of time. As
explained further below, because this is an extension of limited
duration of the telemedicine flexibilities that existed during the
COVID-19 PHE, DEA and HHS have determined that this Fourth Temporary
Rule is consistent ``with effective controls against diversion and
otherwise consistent with the public health and safety'' as required
under 21 U.S.C. 802(54)(G). HHS has advised DEA that no additional
rulemaking by HHS is necessary as it pertains to the promulgation of
these provisions pursuant to 21 U.S.C. 802(54)(G).
III. Purpose and Need for Regulatory Changes
The purpose of this rulemaking is to further extend, for a limited
period of time, the telemedicine flexibilities that existed during the
COVID-19 PHE in order to prevent disruption of care and other problems
that would arise should the Third Extension expire before DEA can
finalize, and stakeholders can implement changes to comply with,
regulations that balance access to care with the necessary safeguards
against diversion.
The Impending Telemedicine Cliff
DEA has received numerous communications from patients, providers,
and other stakeholders warning that expiration of the current
telemedicine flexibilities, without further regulation, could
potentially and abruptly limit patients' access to care until
promulgation of a final set of regulations. The abrupt end to the
ability to prescribe controlled substances to patients who have not had
an in-person medical evaluation is often referred to as the
``telemedicine cliff.'' The potential harms are widespread. To put it
into context, one stakeholder summarized unpublished data reviewed by
Epic, Johns Hopkins, and Stanford: of an estimated 44.6 million
prescriptions for controlled substances prescribed across 258
organizations in 2024, more than 7 million, approximately 16 percent,
were issued without a prior in-person medical evaluation.
We need only examine the recent sunsetting of COVID-era,
congressionally-granted Medicare telemedicine flexibilities to observe
the negative impact a telemedicine cliff has on patients' access to
care when no permanent laws or regulations are in place. The effects of
the abrupt cessation of Medicare's telemedicine flexibilities on
September 30, 2025 were quickly seen in the days following their
[[Page 61304]]
expiration. In an analysis of national data of electronic medical
records, there was a 24 percent reduction of fee-for-service
telemedicine visits in the first 17 days following the September 30,
2025 expiration of Medicare's telemedicine flexibilities. In a wide
range of states, including Florida, Louisiana, Washington, Tennessee,
Maryland, Oklahoma, and New York, the reduction was nearly 40 percent
or more.\13\ Until Congress extended Medicare's telemedicine
flexibilities,\14\ beneficiaries and providers faced disruption in
access to care and loss of timely critical services for patients.\15\
Telemedicine removes barriers to care for patients with transportation
and mobility challenges.\16\ The end of the telemedicine flexibilities,
without further regulation, would reimpose those barriers, which could
lead to lack of access to lifesaving care for some patients.
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\13\ Ateev Mehrotra, Michael L. Barnett, Andrew Wilcock, and
Jared Perkins, Medicare Telehealth Flexibilities at Risk with
Government Shutdown, Brown University School of Public Health,
Center for Advancing Health Policy Through Research (CAHPR), https://cahpr.sph.brown.edu/sites/default/files/documents/Policy%20Briefs/2025/Research%20Brief_%20Medicare%20Telehealth%20Flexibilities%20at%20Risk%20of%20Expiration%20%281%29.pdf (last visited Dec. 2, 2025).
\14\ Julia Ivanova, Ph.D., MA, Senate Passes CR Extending
Medicare Telehealth Flexibilities Through January 2026,
Telehealth.org, Nov. 11, 2025, https://telehealth.org/blog/senate-passes-cr-extending-medicare-telehealth-flexibilities-through-january-2026/.
\15\ Mehrotra, supra note 13.
\16\ Mehrotra, supra note 13.
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Purpose of Regulatory Changes
This extension will postpone the telemedicine cliff and provide the
following benefits:
Prevent disruption of care: Abruptly ending the current
telemedicine flexibilities could significantly disrupt access to care
for patients who rely on telemedicine, particularly those in rural or
underserved areas, the elderly, or individuals with mobility
limitations as well as for patients who do not yet have an existing
telemedicine relationship with their practitioners;
Prevent a backlog of patients needing in-person
appointments: For relationships established both during the COVID-19
PHE and those established during the prior extensions, prevent backlogs
with respect to in-person medical evaluations in the months shortly
before and after the expiration of the telemedicine flexibilities and
ensure the availability of telemedicine for practitioners and patients
who have come to rely on it;
Allow for a smooth transition: Extending the flexibilities
provides the DEA with additional time to finalize and implement
effective regulations that balance access to care with the necessary
safeguards against diversion;
Provide adequate time for implementation: Allow patients,
practitioners, pharmacists, service providers, and other stakeholders
sufficient time to prepare for the implementation of future regulations
that would apply to the prescribing of controlled substances via
telemedicine in cases where the prescribing provider has never
conducted an in-person medical evaluation of the patient.
IV. Summary of Fourth Temporary Rule Changes
This Fourth Temporary Rule amends portions of 21 CFR 1307.41 and 42
CFR 12.1 through December 31, 2026.
Paragraph (a) is amended to state that the authorization granted in
paragraph (b) expires at the end of December 31, 2026, instead of
December 31, 2025.
Paragraph (b) is amended to state that the authorization granted in
paragraph (b) expires at the end of December 31, 2026, instead of
December 31, 2025.
V. Interaction Between This Rulemaking and the Two Final Rules
Published on January 17, 2025
On January 17, 2025, DEA and HHS published two final rules titled
``Expansion of Buprenorphine Treatment via Telemedicine Encounter'' (90
FR 6504, adding 21 CFR 1306.51) and ``Continuity of Care via
Telemedicine for Veterans Affairs Patients'' (90 FR 6523, adding 21 CFR
1306.52), collectively the ``Two Final Rules.'' On February 19, 2025,
DEA and HHS delayed the effective date of these rules until March 21,
2025 (90 FR 9841). On March 24, 2025, DEA and HHS, responding to
comments, further delayed the effective date of the Two Final Rules
until December 31, 2025 (90 FR 13410). The Two Final Rules will go into
effect on December 31, 2025 (90 FR 13410).
Together, the Two Final Rules and this temporary rule describe
three separate and distinct sets of authorities for telemedicine
prescribing, and each imposes a unique set of requirements with respect
to prescribing done pursuant to it. A prescribing practitioner may
issue a prescription via telemedicine under the temporary rule even if
he/she could also issue that prescription under one or both of the Two
Final Rules, provided all the requirements in 21 CFR 1307.41(c)/42 CFR
12.1(c) of this temporary rule are met. Only if a prescription is
issued pursuant to one of the Two Final Rules do the requirements of
the applicable rule need to be met. Thus, even registrants covered by
one or both of the Two Final Rules may continue to utilize the
telemedicine flexibilities under the fourth temporary rule, which
imposes fewer requirements than the Two Final Rules.
VI. Regulatory Analyses
Administrative Procedure Act
DEA and HHS are issuing this temporary rule without prior notice
and an opportunity to comment, within less than 30 days prior to its
effective date of January 1, 2026, pursuant to the ``good cause''
exceptions in the Administrative Procedure Act (APA).\17\ Agencies may
forgo the notice-and-comment and 30-day delayed effective date
requirements under the APA when a rulemaking is published in the
Federal Register and the agency ``for good cause finds . . . that
notice and public procedure thereon are impracticable, unnecessary, or
contrary to the public interest.'' \18\
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\17\ 5 U.S.C. 553(b)(B); 5 U.S.C. 553(d)(3). The 30-day delayed
effective date requirement is also excepted pursuant 5 U.S.C.
553(d)(1) as this rulemaking grants an exemption from the
requirements of the Ryan Haight Act.
\18\ 5 U.S.C. 553(b)(B).
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As discussed earlier, DEA, jointly with HHS, is publishing this
fourth temporary extension of certain exceptions to existing DEA
regulations, granted in March 2020 as a result of the COVID-19 PHE, in
order to prevent the impending telemedicine cliff: the abrupt reduction
of access to care--pending promulgation of a final rule--for patients
that do not have an existing provider-patient relationship with their
provider that is predicated on a prior in-person medical evaluation. It
would be impracticable and contrary to the public interest for DEA and
HHS to publish a notice of proposed rulemaking; await, review, and
respond to new comments; and issue a final rule in the time remaining
before the third extension expires on December 31, 2025. As discussed
more fully above, patients would experience a reduction in access to
care if the existing telemedicine flexibilities ended on December 31,
2025, which could lead to potential harm--due to an inability to access
timely care and potentially lifesaving medication--for some patients.
The abrupt 41-day cessation of Medicare's telemedicine flexibilities on
September 30, 2025, previewed the negative impact a telemedicine cliff
has on patients' access to care when no permanent laws
[[Page 61305]]
or regulations are in place when such flexibilities expire.
For the reasons established above, DEA, jointly with HHS, finds
that notice and public comment on this rule are impracticable and
contrary to the public interest and that there is good cause to make it
effective less than 30 days after its publication.
Executive Orders 12866, 13563, and 14192 (Regulatory Review)
DEA has determined that this rulemaking is a ``significant
regulatory action'' under section 3(f) of Executive Order (E.O.) 12866,
Regulatory Planning and Review, but it is not a section 3(f)(1)
significant action. Accordingly, this temporary rule has been submitted
to the Office of Management and Budget (OMB) for review and has been
drafted and reviewed in accordance with E.O. 12866, Regulatory Planning
and Review, E.O. 13563, Improving Regulation and Regulatory Review, and
E.O. 14192, Unleashing Prosperity Through Deregulation. This temporary
rule is a ``deregulatory action'' under an E.O. 14192, because it is
final and has a total cost less than zero. The net present value of the
estimated cost savings is $17.2 million.\19\
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\19\ On January 17, 2025, DEA published the ``Special
Registrations for Telemedicine and Limited State Telemedicine
Registrations'' NPRM [90 FR 6541], which proposed a framework for a
Special Registration for Telemedicine, pursuant to 21 U.S.C.
802(54)(E), authorizing practitioners and mid-level practitioners
with the Special Registration to prescribe controlled substances via
audio-video telemedicine (and in limited instances, audio-only
telemedicine) without having ever conducted an in-person medical
evaluation of the patient, provided they adhere to the proposed
prescription, recordkeeping, and reporting requirements. DEA
believes the patient cost savings quantified in the NPRM also
applies to this temporary extension. From the NPRM, the estimated
patient cost savings in the first year is $18.4 million, with net
present value of $17.2 million at a seven percent discount rate.
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DEA, jointly with HHS, is publishing this Fourth Temporary Rule to
further extend certain exceptions DEA granted to its existing
regulations in March 2020 as a result of the COVID-19 PHE to avoid a
lapse of care for patients. The additional extension of the COVID-19
flexibilities until December 31, 2026 is necessary to thoroughly
consider the presentations made at the Telemedicine Listening Sessions,
the Tribal Consultations, the E.O. 12866 meetings, as well as the
comments made to the Special Registration for Telemedicine NPRM.
Without this Fourth Temporary Rule, the COVID-19 PHE telemedicine
flexibilities are scheduled to expire on December 31, 2025. This rule
extends the expiration of those flexibilities through December 31,
2026. Because this rule does not create or remove any regulatory
requirements, DEA and HHS estimate that there is no cost associated
with this Fourth Temporary Rule. However, DEA and HHS believe this
extension creates a benefit in the form of cost savings to patients.
Executive Order 12988, Civil Justice Reform
The Fourth Temporary Rule meets the applicable standards set forth
in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This Fourth Temporary Rule does not have federalism implications
warranting the application of E.O. 13132. The rule does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or the distribution of power
and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This Fourth Temporary Rule does not have substantial direct effects
on the Tribes, on the relationship between the national government and
the Tribes, or the distribution of power and responsibilities between
the Federal Government and Indian Tribes. However, DEA has determined
that there is a reasonable basis that the Special Registration for
Telemedicine NPRM may have Tribal implications, consistent with the
definition in E.O. 13175. As such, DEA intends to hold further virtual
consultations with Tribal governments and organizations and address any
concerns raised into the final set of Special Registration for
Telemedicine regulations.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act (5 U.S.C. 601-612) (RFA), has reviewed this Fourth Temporary Rule
and by approving it certifies that it will not have a significant
economic impact on a substantial number of small entities. This Fourth
Temporary Rule, as discussed above, merely extends for a limited time
the status quo with respect to the current flexibilities allowed during
the COVID-19 PHE, in order to avoid lapses in coverage for patients.
Without this Fourth Temporary Rule, the COVID-19 PHE telemedicine
flexibilities would expire on December 31, 2025. While this Fourth
Temporary Rule does not create or remove any regulatory requirements,
this Fourth Temporary Rule extends the expiration of those
flexibilities through December 31, 2026. DEA and HHS believe this
extension creates a benefit in the form of cost savings to prescribers
and patients and reduced transfer payments to the Federal Government.
In accordance with the RFA, DEA will be evaluating the impact on
small entities at the time the final rule or rules are issued as part
of these rulemakings.
Unfunded Mandates Reform Act of 1995
The estimated annual impact of this rule is minimal. Thus, DEA has
determined in accordance with the Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.) that this action would not result in any
federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted for inflation) in any one year.
Therefore, neither a Small Government Agency Plan nor any other action
is required under provisions of UMRA.
Executive Order 14267, Reducing Anti-Competitive Regulatory Barriers
The temporary rule does not reduce competition, entrepreneurship,
and innovation.
Executive Order 14294, Overcriminalization of Federal Regulations
Executive Order 14294 specifies that all NPRMs and final rules
published in the Federal Register, the violation of which may
constitute criminal regulatory offenses, should include a statement
identifying that the rule or proposed rule is a criminal regulatory
offense, the authorizing statute, and the mens rea requirement for each
element of the offense. This temporary final rule does not involve a
criminal regulatory offense and thus E.O. 14294 does not apply.
Congressional Review Act
This temporary rule is not a major rule as defined by Subtitle E of
the Small Business Regulatory Enforcement Fairness Act of 1996 (known
as the Congressional Review Act or CRA).\20\ However, pursuant to the
CRA, DEA is submitting a copy of this temporary rule to both Houses of
Congress and to the Comptroller General.
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\20\ 5 U.S.C. 804(2).
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[[Page 61306]]
Paperwork Reduction Act of 1995
This temporary rule will not impose a new collection or modify an
existing collection of information under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501-3521). Also, this temporary rule does not impose
recordkeeping or reporting requirements on State or local governments,
individuals, businesses, or other organizations. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a valid OMB control
number.
List of Subjects
21 CFR Part 1307
Administrative practice and procedure, Drug traffic control,
Prescription drugs.
42 CFR Part 12
Administrative practice and procedure, Drug traffic control,
Prescription drugs.
Drug Enforcement Administration
For the reasons set out above, the Drug Enforcement Administration
amends 21 CFR part 1307 as follows:
PART 1307--MISCELLANEOUS
0
1. The authority citation for part 1307 continues to read as follows:
Authority: 21 U.S.C. 821, 822(d), 871(b), unless otherwise
noted.
0
2. Revise and republish Sec. 1307.41 to read as follows:
Sec. 1307.41 Temporary extension of certain COVID-19 telemedicine
flexibilities for prescription of controlled medications.
(a) This section is in effect until the end of the day December 31,
2026. The authorization granted in paragraph (b) of this section
expires at the end of December 31, 2026.
(b) During the period May 12, 2023, through December 31, 2026, a
DEA-registered practitioner is authorized to prescribe schedule II-V
controlled substances via telemedicine, as defined in 21 CFR
1300.04(i), to a patient without having conducted an in-person medical
evaluation of the patient if all of the conditions listed in paragraph
(c) of this section are met.
(c) A practitioner is only authorized to issue prescriptions for
controlled substances pursuant to paragraph (b) of this section if all
of the following conditions are met:
(1) The prescription is issued for a legitimate medical purpose by
a practitioner acting in the usual course of professional practice;
(2) The prescription is issued pursuant to a communication between
a practitioner and a patient using an interactive telecommunications
system referred to in 42 CFR 410.78(a)(3);
(3) The practitioner is:
(i) Authorized under their registration under 21 CFR
1301.13(e)(1)(iv) to prescribe the basic class of controlled substance
specified on the prescription; or
(ii) Exempt from obtaining a registration to dispense controlled
substances under 21 U.S.C. 822(d); and
(4) The prescription is consistent with all other requirements of
21 CFR part 1306.
Department of Health and Human Services
For the reasons set out above, the Department of Health and Human
Services amends 42 CFR part 12 as follows:
PART 12--TELEMEDICINE FLEXIBILITIES
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3. The authority citation for part 12 continues to read as follows:
Authority: 21 U.S.C. 802(54)(G).
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4. Revise and republish Sec. 12.1 to read as follows:
Sec. 12.1 Temporary extension of certain COVID-19 telemedicine
flexibilities for prescription of controlled medications.
(a) This section is in effect until the end of the day December 31,
2026. The authorization granted in paragraph (b) of this section
expires at the end of December 31, 2026.
(b) During the period May 12, 2023, through December 31, 2026, a
Drug Enforcement Administration (DEA)-registered practitioner is
authorized to prescribe Schedule II-V controlled substances via
telemedicine, as defined in 21 CFR 1300.04(i), to a patient without
having conducted an in-person medical evaluation of the patient if all
of the conditions listed in paragraph (c) of this section are met.
(c) A practitioner is only authorized to issue prescriptions for
controlled substances pursuant to paragraph (b) of this section if all
of the following conditions are met:
(1) The prescription is issued for a legitimate medical purpose by
a practitioner acting in the usual course of professional practice;
(2) The prescription is issued pursuant to a communication between
a practitioner and a patient using an interactive telecommunications
system referred to in 42 CFR 410.78(a)(3);
(3) The practitioner is:
(i) Authorized under their registration under 21 CFR
1301.13(e)(1)(iv) to prescribe the basic class of controlled substance
specified on the prescription; or
(ii) Exempt from obtaining a registration to dispense controlled
substances under 21 U.S.C. 822(d); and
(4) The prescription is consistent with all other requirements of
21 CFR part 1306.
Signing Authority
This document of the Drug Enforcement Administration was signed on
December 15, 2025, by Administrator Terrance C. Cole. That document
with the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Gregory Aul,
Federal Register Liaison Officer, Drug Enforcement Administration.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-24123 Filed 12-30-25; 8:45 am]
BILLING CODE 4410-09-P