[Federal Register Volume 88, Number 194 (Tuesday, October 10, 2023)]
[Rules and Regulations]
[Pages 69879-69883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22406]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1307

[Docket No. DEA-407]
RIN 1117-AB40 and 1117-AB78

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 12


Second 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: On March 1, 2023 the Drug Enforcement Administration (DEA), in 
concert with the Department of Health and Human Services (HHS), 
promulgated two notices of proposed rulemakings (NPRMs) soliciting 
comments on proposals to allow for prescribing of controlled 
medications pursuant to the practice of telemedicine in instances where 
the prescribing practitioner has never conducted an in-person medical 
evaluation of the patient. On May 10, 2023, following initial review of 
the comments received, DEA, jointly with HHS, issued a temporary rule 
(First Temporary Rule) extending certain exceptions granted to existing 
DEA regulations in March 2020 as a result of the COVID-19 Public Health 
Emergency (COVID-19 PHE). These exceptions were granted in order to 
avoid lapses in care for patients. In particular, with respect to 
practitioner-patient relationships formed after the May 11, 2023, 
expiration of the COVID-19 PHE, the First Temporary Rule extended the 
temporary exceptions until November 11, 2023. In this second temporary 
rule, as DEA and HHS continue to consider revisions to the proposed 
rules set forth in the March 1, 2023 NPRMs and in light of Telemedicine 
Listening Sessions that DEA hosted on September 12 and 13, 2023, DEA 
and HHS are further extending such exceptions to existing DEA 
regulations for new practitioner-patient relationships through December 
31, 2024.

DATES: As of November 11, 2023, the end of the effective period for the 
temporary rule published at 88 FR 30037 on May 10, 2023, is extended 
from November 11, 2024, to December 31, 2024. This rule is effective 
November 11, 2023.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, VA 22152, Telephone: (571) 776-3882.

SUPPLEMENTARY INFORMATION: 

I. Background

Overview

    Under the Ryan Haight Online Pharmacy Consumer Protection Act of 
2008 (the Ryan Haight Act), a prescribing practitioner--subject to 
certain exceptions--may prescribe controlled medications to a patient 
only after conducting an in-person evaluation of that patient. In 
response to the COVID-19 Public Health Emergency (COVID-19 PHE), as 
declared by the Secretary (the Secretary) of the Department of Health 
and Human Services (HHS) on January 31, 2020, pursuant to the authority 
under section 319 of the Public Health Service Act (42 U.S.C. 247), the 
Drug Enforcement Administration (DEA) granted temporary exceptions to 
the Ryan Haight Act and DEA's implementing regulations under 21 U.S.C. 
802(54)(D).
    In order to prevent lapses in care, these exceptions allowed for 
the prescribing of controlled medications via telemedicine encounters 
even when the prescribing practitioner had not conducted an in-person 
medical evaluation of the patient. These 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); \1\ and
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    \1\ 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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[[Page 69880]]

     A March 31, 2020 ``Dear Registrant'' letter signed by 
Thomas W. Prevoznik, DEA's then-Deputy Assistant Administrator, 
Diversion Control Division (the Prevoznik Letter).\2\
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    \2\ 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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    On March 1, 2023, DEA, in concert 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'' \3\ (the 
General Telemedicine Rule) and ``Expansion of Induction of 
Buprenorphine via Telemedicine Encounter'' \4\ (the Buprenorphine 
Rule)--which proposed to expand patient access to prescriptions for 
controlled medications via telemedicine encounters relative to the pre-
COVID-19 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 Rule and 2,915 comments on the 
Buprenorphine Rule.
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    \3\ 88 FR 12875 (Mar. 1, 2023).
    \4\ 88 FR 12890 (Mar. 1, 2023).
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    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 Rule, which extended the full set of 
telemedicine flexibilities regarding the prescribing of controlled 
medications, as had been in place under the COVID-19 PHE, through 
November 11, 2023.\5\ The First Temporary Rule also provided a one-year 
grace period, through November 11, 2024, to any practitioner-patient 
telemedicine relationships that have been or will be established on or 
before November 11, 2023. In other words, under the First Temporary 
Rule, 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 would 
continue to apply through November 11, 2024.
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    \5\ Temporary Extension of COVID-19 Telemedicine Flexibilities 
for Prescription of Controlled Medications, 88 FR 30037 (May 10, 
2023).
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    On August 7, 2023, DEA announced that it would host Telemedicine 
Listening Sessions on September 12 and 13, 2023 to receive additional 
input concerning the practice of telemedicine with regards to 
prescribing controlled medications and potential safeguards that could 
effectively prevent and detect diversion of controlled substances 
prescribed via telemedicine. DEA is carefully evaluating the 
information and perspectives presented at the Telemedicine Listening 
Sessions, as well as the comments received in response to the NPRMs, as 
DEA and HHS develop regulations providing access to the practice of 
telemedicine when consistent with public health and safety, and that 
also effectively mitigate the risk of possible diversion.
    In light of the need to further evaluate the best course of action 
given the comments received in response to the NPRMs and the 
presentations at the Telemedicine Listening Sessions, DEA, jointly with 
HHS, is issuing this second temporary rule (``Second Temporary Rule'') 
extending the full set of telemedicine flexibilities regarding 
prescription of controlled medications as were in place during the 
COVID-19 PHE, through December 31, 2024. This extension authorizes all 
DEA-registered practitioners to prescribe schedule II-V controlled 
medications via telemedicine through December 31, 2024, whether or not 
the patient and practitioner established a telemedicine relationship on 
or before November 11, 2023. In other words, the grace period provided 
in the First Temporary Rule is effectively subsumed by this Second 
Temporary Rule, which continues the extension of the current 
flexibilities for all practitioner-patient relationships--not just 
those established on or before November 11, 2023--until the end of 
2024.
    The purpose of this Second Temporary Rule, like the one before it, 
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 allowing adequate time for 
providers to come into compliance with any new standards or safeguards. 
DEA is working to promulgate new standards or safeguards by the fall of 
2024.

II. Legal Authority

    The Ryan Haight Act amended the Controlled Substances Act (CSA) to 
generally require that the dispensing of controlled medications by 
means of the internet be predicated on a valid prescription involving 
at least one in-person medical evaluation.\6\ At the same time, it also 
established excepted categories of telemedicine pursuant to which a 
practitioner may prescribe controlled medications for a patient despite 
never having evaluated that patient in person, provided that, among 
other things, such practice is in accordance with applicable Federal 
and State laws.\7\
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    \6\ 21 U.S.C. 829(e).
    \7\ 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.
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    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 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.'' \8\
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    \8\ 21 U.S.C. 802(54)(G).
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    Pursuant to this authority, DEA, jointly with HHS, is hereby 
promulgating this Second Temporary Rule specifying certain 
circumstances under which practitioners may prescribe controlled 
medications, for the time period described above, to patients whom the 
practitioner has never evaluated in person. This Second Temporary Rule, 
like the First Temporary Rule, covers the portions of the NPRM related 
to extensions of the telemedicine flexibilities in place during the 
COVID-19 PHE, and it extends, through December 31, 2024, the 
telemedicine flexibilities that have been in place since March 2020 for 
prescribing controlled medications via the practice of telemedicine.
    As noted previously, DEA and/or HHS anticipate implementing a final 
set of regulations providing access to the practice of telemedicine 
when consistent with public health and safety, and that also 
effectively mitigate the risk of possible diversion. However, given the 
impending expiration of the flexibilities provided in the First 
Temporary Rule and the additional

[[Page 69881]]

consideration of the input received during the Telemedicine Listening 
Sessions, DEA, jointly with HHS, has elected to again extend those 
flexibilities to maintain access to care during a limited window of 
time as they consider the appropriate pathway forward.
    As explained further below, because this is an extension of limited 
duration of flexibilities that existed during the COVID-19 PHE, and 
because there are legitimate concerns regarding patient access to care 
following the expiration the practitioner-patient relationship aspect 
of the First Temporary Rule on November 11, 2023, DEA and HHS have 
determined that this Second 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). DEA, 
jointly with HHS, is promulgating this temporary rule pursuant to 21 
U.S.C. 802(54)(G).
    HHS also 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 a reduction in access to care for patients who do 
not yet have an existing telemedicine relationship with their 
practitioners pending promulgation of a final rule or rules addressing 
telemedicine more generally.
     For relationships established both during the COVID-19 PHE 
and those established shortly after, 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;
     Address the urgent public health need for continued access 
to the initiation of buprenorphine as medication for opioid use 
disorder in the context of the continuing opioid public health crisis;
     Allow patients, practitioners, pharmacists, service 
providers, and other stakeholders sufficient time to prepare for the 
implementation of any future regulations that apply to prescribing of 
controlled medications via telemedicine;
     Enable DEA and potentially HHS to thoroughly consider the 
presentations made at the Telemedicine Listening Sessions;
     Enable DEA, jointly with HHS, to conduct a thorough 
evaluation of regulatory alternatives in order to promulgate 
regulations that most effectively expand access to telemedicine 
encounters in a manner that is consistent with public health and 
safety, while also effectively mitigating against the risk of possible 
diversion; and
     Avoid incentivizing the investment necessary to develop 
new telemedicine companies that might encourage or enable problematic 
prescribing practices by limiting the second extension of flexibilities 
to a short, time-limited period.

IV. Summary of Second Temporary Rule Changes

    This Second Temporary Rule amends portions of 21 CFR 1307.41 and 42 
CFR 12.1 through December 31, 2024.
    Paragraph (a) is amended to state that the authorization granted in 
the amended paragraph (c) expires at the end of December 31, 2024, 
instead of November 11, 2023.
    Paragraph (c) is amended to extend the COVID-19 telemedicine 
prescribing flexibilities from May 12, 2023 through December 31, 2024, 
provided all of the conditions listed in paragraph (e) are met.

V. Regulatory Analyses

Administrative Procedure Act

    DEA and HHS are issuing this rule without prior notice and an 
opportunity to comment pursuant to the Administrative Procedure Act's 
(APA's) ``good cause'' exception. In certain circumstances, agencies 
may forgo notice-and-comment rulemaking 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.'' \9\
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    \9\ 5 U.S.C. 553(b)(B).
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    As discussed earlier, DEA, jointly with HHS, is publishing this 
second temporary extension of certain exceptions granted to existing 
DEA regulations in March 2020 as a result of the COVID-19 PHE in order 
to prevent a reductionin access to care for patients that do not yet 
have an existing telemedicine relationship with their practitioners 
pending promulgation of a final rule or rules addressing telemedicine 
more generally. It would be impracticable for DEA and HHS to publish a 
notice of proposed rulemaking; await, review, and respond to new 
comments; and issue a rule in the time remaining before the first 
extension expires on November 11, 2023. Further, the reduction in 
access to care that patients would experience if the existing 
telemedicine flexibilities ended on November 11, 2023 would be contrary 
to the public interest, as it could lead to potential patient harm--due 
to an inability to access appropriate care--in some instances.
    As noted above, earlier this year DEA received 38,369 comments on 
two proposed rules regarding the flexibilities to be extended by this 
rule. DEA considered those comments in publishing the First Temporary 
Rule.\10\ Moreover, any final rule or rules that DEA and/or HHS 
promulgate addressing telemedicine more generally would reflect 
viewpoints and information from comments received in response to the 
proposed rules, the Telemedicine Listening Sessions, and any further 
comments that may be collected during additional rounds of public 
comment. Because the public has so recently had the opportunity to 
comment on these flexibilities and because DEA and HHS continue to 
consider information that was provided in those comments and that may 
be provided in the near future before issuing a final set of 
regulations, further opportunity for public comment on these 
flexibilities at this time would serve little, if any, purpose.
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    \10\ 88 FR 30037, 30039-30041 (May 10, 2023).
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    For these reasons, each of which individually constitutes good 
cause, DEA, jointly with HHS, finds that notice and public comment on 
this rule are impracticable, unnecessary, and contrary to the public 
interest.

Executive Orders 12866 (Regulatory Planning and Review), 13563 
(Improving Regulation and Regulatory Review), and 14094 (Modernizing 
Regulatory Review)

    This Second Temporary Rule was developed in accordance with the 
principles of Executive Orders (E.O.) 12866, as amended by E.O. 14094 
and E.O. 13563. E.O. 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health, and safety 
effects; distributive impacts; and equity). E.O. 13563 is supplemental 
to and reaffirms the principles, structures, and definitions governing 
regulatory review established in E.O. 12866.

[[Page 69882]]

    The economic, interagency, budgetary, legal, and policy 
implications of this proposed rule have been examined, and DEA has 
determined that it is a significant regulatory action under E.O. 12866, 
but not a Section 3(f)(1) significant regulatory action. Accordingly, 
this rule has been submitted to the Office of Management and Budget 
(OMB) for review.
    DEA, jointly with HHS, is publishing this Second Temporary Rule to 
further extend certain exceptions DEA granted to its existing 
regulations in March 2020 as a result of the COVID-19 PHE in order to 
avoid a lapse of care for patients. The additional extension until 
December 31, 2024, of the COVID-19 flexibilities is necessary to 
thoroughly consider the presentations made at the Telemedicine 
Listening Sessions, as well as the comments made to the proposed rules 
set forth in the NPRMs.
    Without this Second Temporary Rule, COVID-19 PHE telemedicine 
flexibilities are scheduled to expire on November 11, 2023, with 
respect to practitioner-patient relationships established after that 
date. This rule extends the expiration of those flexibilities for new 
practitioner-patient relationships through December 31, 2024. Because 
this rule does not create or remove any regulatory requirements, DEA 
and HHS estimate that there is no cost associated with this Second 
Temporary Rule. However, DEA and HHS believe this extension creates a 
benefit in form of cost savings to prescribers and patients and reduced 
transfer payments to the Federal Government, similar to those described 
in the General Telemedicine Rule.
    However, due to the nature of this rule, differing policies between 
the flexibilities being extended with this Second Temporary Rule and 
the flexibilities still proposed in the General Telemedicine Rule, and 
any additional policy that may be addressed in one or more final rules, 
DEA is unable to quantify the cost savings and reduction in transfer 
payments.

Executive Order 12988, Civil Justice Reform

    The Second Temporary Rule meets the applicable standards set forth 
in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to 
eliminate ambiguity, minimize litigation, establish clear legal 
standards, and reduce burden.

Executive Order 13132, Federalism

    This Second 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 Second 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.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act (5 U.S.C. 601-612) (RFA), has reviewed this Second Temporary Rule 
and by approving it certifies that it will not have a significant 
economic impact on a substantial number of small entities. This Second 
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 Second Temporary Rule, COVID-19 PHE telemedicine 
flexibilities would expire on November 11, 2023, with respect to 
practitioner-patient relationships established after that date. While 
this Second Temporary Rule does not create or remove any regulatory 
requirements, this Second Temporary Rule extends the expiration of 
those flexibilities through December 31, 2024. DEA and HHS believe this 
extension create a benefit in 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.

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.

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).\11\ 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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    \11\ 5 U.S.C. 804(2).
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Signing Authority

    This document of the Drug Enforcement Administration and the 
Department of Health and Human Services was signed on October 4, 2023, 
by DEA Administrator Anne Milgram. Those documents with the original 
signatures and dates 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.

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.

21 CFR Chapter II

    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. Amend Sec.  1307.41 by revising paragraphs (a) and (c) 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, 
2024. The authorization granted in paragraph (c) of this section 
expires at the end of December 31, 2024.
* * * * *
    (c) During the period May 12, 2023, through December 31, 2024, a 
DEA-

[[Page 69883]]

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 
(e) of this section are met.
* * * * *

42 CFR Chapter I

    For the reasons set out above, the Department of Health and Human 
Services amends 42 CFR part 12 as follows:

PART 12--TELEMEDICINE FLEXIBILITIES

0
3. The authority citation for part 12 continues to read as follows:

    Authority: 21 U.S.C. 802(54)(G).


0
4. Amend Sec.  12.1 by revising the section heading and paragraphs (a) 
and (c) 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, 
2024. The authorization granted in paragraph (c) of this section 
expires at the end of December 31, 2024.
* * * * *
    (c) During the period May 12, 2023, through December 31, 2024, 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 (e) of this section are met.
* * * * *

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
Miriam E. Delphin-Rittmon,
Assistant Secretary for Mental Health and Substance Use, Department of 
Health and Human Services, and Administrator, Substance Abuse and 
Mental Health Services Administration.
[FR Doc. 2023-22406 Filed 10-6-23; 8:45 am]
BILLING CODE 4410-09-P