[Federal Register Volume 90, Number 55 (Monday, March 24, 2025)]
[Rules and Regulations]
[Pages 13410-13412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-05007]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1306
[Docket No. DEA-948; DEA-407VA]
RIN 1117-AB78; 1117-AB40; 1117-AB88
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 12
Expansion of Buprenorphine Treatment via Telemedicine Encounter
and Continuity of Care via Telemedicine for Veterans Affairs Patients
AGENCY: Drug Enforcement Administration, Department of Justice;
Substance Abuse and Mental Health Services Administration, Department
of Health and Human Services.
ACTION: Final rule.
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SUMMARY: In the January 17, 2025, issue of the Federal Register, the
Drug Enforcement Administration and the Department of Health and Human
Services published two final rules related to the practice of
telemedicine, titled ``Expansion of Buprenorphine Treatment via
Telemedicine Encounter'' and ``Continuity of Care via Telemedicine for
Veterans Affairs Patients.'' These final rules were originally
scheduled to become final on February 18, 2025. In accordance with the
Presidential Memorandum of January 20, 2025, titled ``Regulatory Freeze
Pending Review,'' the Drug Enforcement Administration and the
Department of Health and Human Services delayed the effective dates of
these two final rules to March 21, 2025, by issuing a final rule; delay
of effective dates and request for comments in the February 19, 2025,
issue of the Federal Register. The Drug Enforcement Administration
received 32 comments in response to the request for public comments
regarding the delayed effective date. Considering these comments, the
Department of Justice wishes to further postpone the effective dates
for the purpose of further reviewing any questions of fact, law, and
policy that the rules may raise. Therefore, the Drug Enforcement
Administration and the Department of Health and Human Services will
delay the effective date of the two final rules titled ``Expansion of
Buprenorphine Treatment via Telemedicine Encounter'' and ``Continuity
of Care via Telemedicine for Veterans Affairs Patients'' to December
31, 2025.
DATES: As of March 20, 2025, the effective dates of the final rules
amending 21 CFR part 1306 and 42 CFR part 12 published in the Federal
Register on January 17, 2025, at 90 FR 6504 and 90 FR 6523,
respectively, are effective December 31, 2025.
FOR FURTHER INFORMATION CONTACT: Heather Achbach, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 776-3882.
SUPPLEMENTARY INFORMATION:
Discussion
On January 17, 2025, the Drug Enforcement Administration (DEA) and
the Department of Health and Human Services (HHS) published two final
rules titled ``Expansion of Buprenorphine Treatment via Telemedicine
Encounter'' (90 FR 6504) and ``Continuity of Care via Telemedicine for
Veterans Affairs Patients'' (90 FR 6523). These rules, respectively,
amended their regulations to expand the circumstances under which: (1)
practitioners registered by DEA are authorized to prescribe schedule
III-V controlled substances approved by the Food and Drug
Administration for the treatment of opioid use disorder via a
telemedicine encounter, including an audio-only telemedicine encounter
\1\ and (2) Department of Veterans Affairs practitioners acting within
the scope of their Veterans Affairs employment are authorized to
prescribe schedule II-V controlled substances via telemedicine to a
Veterans Affairs patient with whom they have not conducted an in-person
medical evaluation, if another Veterans Affairs practitioner has, at
any time, previously conducted an in-person medical evaluation of the
Veterans Affairs patient, subject to certain conditions.\2\
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\1\ 90 FR 6504 (Jan. 17, 2025).
\2\ 90 FR 6523 (Jan. 17, 2025).
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On January 20, 2025, the President of the United States issued a
memorandum to all executive departments and agencies titled
``Regulatory Freeze
[[Page 13411]]
Pending Review'' (the Freeze Memo).\3\ Paragraph 3 of the Freeze Memo
ordered agencies to ``consider postponing for 60 days from the date of
this memorandum the effective date for any rules that have been
published in the Federal Register, or any rules that have been issued
in any manner but have not taken effect, for the purpose of reviewing
any questions of fact, law, and policy that the rules may raise.'' The
purpose of this delay was ``to allow interested parties to provide
comments about issues of fact, law, and policy raised by the rules
postponed under this memorandum, and consider reevaluating pending
petitions involving such rules.'' In accordance with the Freeze Memo,
DEA and HHS published a final rule; delay of effective dates and
request for comment in the February 19, 2025, issue of the Federal
Register.\4\
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\3\ 90 FR 8249 (Jan. 28, 2025).
\4\ 90 FR 9841 (Feb. 19, 2025).
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In the preamble to that rule, DEA explained that the ``new
effective dates will not delay or limit the ability of the
practitioners covered by these two rules to prescribe via telemedicine,
because the `Temporary Extension of COVID-19 Telemedicine Flexibilities
for Prescription of Controlled Medications,' which has been in effect
since May 10, 2023, permits practitioners to prescribe via telemedicine
through December 31, 2025.'' \5\ In addition, this delay allowed
Department of Justice (DOJ) and HHS officials further opportunity to
review any potential questions of fact, law, and policy raised by those
two final rules.
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\5\ 90 FR 9841, 98842 (citing 88 FR 30037 (May 10, 2023), as
extended by 88 FR 30037 (May 10, 2023) and 89 FR 91253 (Nov. 19,
2024)).
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DEA solicited public comment regarding the delayed effective dates
of these two final rules. DEA also solicited public comment on whether
there may be a need for their effective dates to be extended beyond the
new effective date of March 21, 2025, and to address issues of fact,
law, and policy raised by these rules, for consideration by officials
of the two agencies. DEA received a total of 32 comments. Of the 32
comments received, three commenters specifically requested a further
delay in the effective date of the two final rules and 13 commenters
requested that the final rules become effective as soon as possible.
Since a new effective date will not delay or limit the ability of the
practitioners covered by these two rules to prescribe via telemedicine,
because the `Temporary Extension of COVID-19 Telemedicine Flexibilities
for Prescription of Controlled Medications permits practitioners to
prescribe via telemedicine through December 31, 2025, and to allow DOJ
additional time to further review any questions of fact, law, and
policy that the rules may raise, DEA and HHS will further delay the
effective date of the two final rules published in the January 17,
2025, issue of the Federal Register, titled ``Expansion of
Buprenorphine Treatment via Telemedicine Encounter'' \6\ and
``Continuity of Care via Telemedicine for Veterans Affairs Patients''
\7\ to December 31, 2025. This document finalizes the delayed effective
date of these final rules to December 31, 2025.
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\6\ 90 FR 6504 (Jan. 17, 2025).
\7\ 90 FR 6523 (Jan. 17, 2025).
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Comments Received
DEA received 32 comments in response to the request for comments
regarding the effective date of the two final rules in the January 17,
2025, issue of the Federal Register, titled ``Expansion of
Buprenorphine Treatment via Telemedicine Encounter'' \8\ and
``Continuity of Care via Telemedicine for Veterans Affairs
Patients''.\9\ Of these comments, 13 commenters requested to finalize
the effective date of the two final rules as soon as possible, which
was scheduled to be March 21, 2025.
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\8\ 90 FR 6504 (Jan. 17, 2025).
\9\ 90 FR 6523 (Jan. 17, 2025).
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Three commenters explicitly requested that the effective date be
delayed beyond March 21, 2025; however, these comments did not provide
an alternative effective date for these two final rules. Four
commenters generally agreed with the final rules without specifying a
preference with respect to their effective dates. Eleven commenters
expressed concerns unrelated to the effective date. One commenter
provided general comments but did not respond with respect to the
delayed effective date.
Based on the foregoing reasons, DEA and HHS are further delaying
the effective date of the two final rules published in the January 17,
2025, issue of the Federal Register titled ``Expansion of Buprenorphine
Treatment via Telemedicine Encounter'' \10\ and ``Continuity of Care
via Telemedicine for Veterans Affairs Patients'' \11\ to December 31,
2025.
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\10\ 90 FR 6504 (Jan. 17, 2025).
\11\ 90 FR 6523 (Jan. 17, 2025).
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Regulatory Analyses
Change to the effective date of these final rules does not affect
the economic impact calculated in the final rules. Per Office of
Management and Budget (OMB) Circular A-4, analysis is conducted on a
time frame which includes all important benefits and costs, and such
time frame generally begins at the point when the final rule is
expected to begin to have effects.\12\ No portion of the analysis
conducted in these final rules was dependent on the original effective
date, and therefore the change in the time frame does not change any
part of the analysis.
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\12\ OMB Circular A-4, section 3(b): ``The time frame for your
analysis should include a period before and after the date of
compliance that is long enough to encompass all the important
benefits and costs likely to result from the regulation. A logical
beginning point for your stream of estimates would be the point in
which the regulation will begin to have effects. . .''
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Executive Orders 12866 and 13563 (Regulatory Review)
The change to the effective date has no change on the analysis
conducted in this section in these two rules. This document merely
effectuates a limited delay in the effective dates of two rules,
previously scheduled to take effect March 21, 2025. There is no change
to the substance of these two final rules.
Regulatory Flexibility Act
The change to the effective date has no change on the analysis
conducted in this section in the final rules.
Paperwork Reduction Act of 1995
The change to the effective date has no change on the analysis
conducted in this section in the final rules.
Executive Order 12988, Civil Justice Reform
This document 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 document does not have federalism implications warranting the
application of E.O. 13132. The document does not have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
DEA and HHS are committed to the principles of collaboration and
consultation with Tribal governments, as demonstrated through its plans
to
[[Page 13412]]
conduct the appropriate Executive Order 13175 Tribal consultations and
recognizes the significance of these consultations and their role in
shaping regulations that impact Tribal communities. Relevant issues
regarding Tribal Consultation were discussed in the two final rules
published on January 17, 2025.
Unfunded Mandates Reform Act of 1995
The estimated annual impact of this notice is minimal. Thus, DEA
and HHS have 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.
Signing Authority
This document of the Drug Enforcement Administration was signed on
March 19, 2025, by Acting Administrator Derek Maltz. 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.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-05007 Filed 3-20-25; 4:15 pm]
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