Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 91253-91257 [2024-27018]
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The technical amendments do not
impose any new substantive regulatory
requirements on any person and merely
reflect the vacatur of the Private Fund
Adviser Rules. For these reasons, for
good cause, the Commission finds that
notice and public comment are
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For similar reasons, although the APA
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IN THE FEDERAL REGISTER].5
Pursuant to the Congressional Review
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List of Subjects in 17 CFR Part 275
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Text of Amendments
For the reasons set forth in the
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of Federal Regulations is amended as
follows:
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Section 275.204–2 is also issued under 15
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§ 275.204–2
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[Amended]
2. Amend § 275.204–2 by:
a. Removing the ‘‘; and’’ at the end of
paragraph (a)(7)(iv)(B) and adding a
period in its place;
■ b. Removing paragraph (a)(7)(v); and
■ c. Removing and reserving paragraphs
(a)(20) through (24).
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4 This
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effective notwithstanding the requirement of 5
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(requiring a final regulatory flexibility analysis only
for rules required by the APA or other law to
undergo notice and comment).
5 See 5 U.S.C. 553(d)(3).
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[Amended]
4. Amend § 275.206(4)–7 by revising
paragraph (b) to read as follows:
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(b) Annual review. Review, no less
frequently than annually, the adequacy
of the policies and procedures
established pursuant to this section and
the effectiveness of their
implementation; and
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■
§ 275.211(h)(1)–1 through § 275.211(h)(2)–3
[Removed]
5. Remove §§ 275.211(h)(1)–1,
275.211(h)(1)–2, 275.211(h)(2)–1,
275.211(h)(2)–2, and 275.211(h)(2)–3.
■
Dated: November 8, 2024.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2024–26524 Filed 11–18–24; 8:45 am]
BILLING CODE 8011–01–P
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4a, 80b–6(4), 80b–6a, 80b–11, 1681w(a)(1),
6801–6809, and 6825, unless otherwise
noted.
*
§ 275.206(4)–7
21 CFR Part 1307
1. The authority citation for part 275
continues to read in part as follows:
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3. Remove §§ 275.206(4)–9 and
275.206(4)–10.
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Drug Enforcement Administration
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[Removed]
DEPARTMENT OF JUSTICE
PART 275—RULES AND
REGULATIONS, INVESTMENT
ADVISERS ACT OF 1940
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§ 275.206(4)–9, § 275.206(4)–10
RIN 1117–AB40, 1117–AB78, and 1117–
ZA06
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 12
Third Temporary Extension of COVID–
19 Telemedicine Flexibilities for
Prescription of Controlled Medications
Drug Enforcement
Administration, Department of Justice;
Substance Abuse and Mental Health
Services Administration, Department of
Health and Human Services.
ACTION: Temporary rule.
AGENCY:
The Drug Enforcement
Administration (DEA) in concert with
the Department of Health and Human
Services (HHS) is issuing a third
extension of telemedicine flexibilities
for the prescribing of controlled
medications, through December 31,
2025.
SUMMARY:
This rule is effective January 1,
2025, through December 31, 2025.
FOR FURTHER INFORMATION CONTACT:
Heather E. Achbach, Diversion Control
DATES:
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91253
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
• A March 31, 2020 ‘‘Dear Registrant’’
letter signed by Thomas W. Prevoznik,
DEA’s then-Deputy Assistant
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%20
reciprocity%20(final)(Signed).pdf.
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Administrator, Diversion Control
Division (the Prevoznik Letter).2
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
NPRM) and ‘‘Expansion of Induction of
Buprenorphine via Telemedicine
Encounter’’ 4 (the Buprenorphine
NPRM)—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 NPRM and
2,915 comments on the Buprenorphine
NPRM. Many of those comments
requested changes of varying degrees to
the proposed regulations in the two
March 2023 NPRMs.
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
(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 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 established a
telemedicine relationship on or before
November 11, 2023, the same
telemedicine flexibilities that had
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%20
buprenorphine%20telemedicine%20%20
(Final)%20+Esign.pdf.
3 88 FR 12875 (Mar. 1, 2023).
4 88 FR 12890 (Mar. 1, 2023).
5 Temporary Extension of COVID–19
Telemedicine Flexibilities for Prescription of
Controlled Medications, 88 FR 30037 (May 10,
2023).
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governed the relationship to that point
would continue to apply through
November 11, 2024.
On August 7, 2023, DEA announced
that it would host Telemedicine
Listening Sessions on September 12 and
13, 2023, in order 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.
On October 10, 2023, DEA, jointly with
HHS, issued a second temporary
extension (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, 2024.6 This extension
authorized 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 was
effectively subsumed by this Second
Temporary Rule, which continued 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.
On June 13 and 27, 2024, DEA held
virtual Tribal Consultations with
numerous Tribal governments and
organizations in order to elicit further
comment from interested Tribal parties
regarding the prescribing of controlled
medications via telemedicine and its
impact on Tribal persons. Additionally,
in June 2024, DEA transmitted a new
draft telemedicine NPRM to the Office
of Management and Budget (OMB) for
review under Executive Order (E.O.)
12866. Since then, DEA has also
attended several meetings with
interested parties coordinated by OMB
pursuant to E.O. 12866, which have
provided interested parties with the
opportunity to provide further views to
OMB.
With the deadline of December 31,
2024, granted by the Second Temporary
Rule quickly approaching, DEA, jointly
with HHS, is now issuing a third
temporary extension (Third Temporary
Rule) to ensure a smooth transition for
patients and practitioners that have
come to rely on the availability of
6 Second Temporary Extension of COVID–19
Telemedicine Flexibilities for Prescription of
Controlled Medications, 88 FR 69879 (October 10,
2023).
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telemedicine for controlled medication
prescriptions. This additional time will
allow DEA (and also HHS, for rules that
must be issued jointly) to promulgate
proposed and final regulations that are
consistent with public health and safety,
and that also effectively mitigate the risk
of possible diversion. Furthermore, this
Third Temporary Rule will allow
adequate time for providers to come into
compliance with any new standards or
safeguards eventually adopted in a final
set of regulations. DEA remains
committed to carefully evaluating the
comments received in response to the
prior NPRMs, as well as the information
and perspectives presented at the
Telemedicine Listening Sessions, the
Tribal Consultations, and the E.O. 12866
meetings.
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 inperson medical evaluation.7 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.8
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 inperson 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.’’ 9
Pursuant to this authority, DEA,
jointly with HHS, is hereby
promulgating this Third Temporary
Rule specifying certain circumstances
under which practitioners may
7 21
U.S.C. 829(e).
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.
9 21 U.S.C. 802(54)(G).
8 21
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prescribe controlled medications, for the
time period described above, to patients
whom the practitioner has never
evaluated in person. This Third
Temporary Rule, like the First and
Second 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, 2025, 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, for
rules that must be issued jointly, HHS
anticipate implementing a final set of
regulations that are consistent with the
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 Second Temporary Rule
and the additional consideration of the
input received during the Telemedicine
Listening Sessions, the Tribal
Consultations, and the E.O. 12866
meetings, DEA, jointly with HHS, has
elected to again extend those
flexibilities to maintain access to care
during a limited window of time as the
agencies 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, DEA and HHS have
determined that this Third 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). Thus, DEA, jointly with
HHS, is promulgating this temporary
rule pursuant to 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 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 during the prior extensions,
prevent backlogs with respect to in-
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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
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 to continue considering
the presentations made at the
Telemedicine Listening Sessions, the
Tribal Consultations, and the E.O. 12866
meetings;
• Enable DEA, with HHS for rules
that must be issued jointly, 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 the
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 third extension of
flexibilities to a short, time-limited
period.
IV. Summary of Third Temporary Rule
Changes
This Third Temporary Rule amends
portions of 21 CFR 1307.41 and 42 CFR
12.1 through December 31, 2025.
Paragraph (a) is amended to state that
the authorization granted in the
amended paragraph (c) expires at the
end of December 31, 2025, instead of
December 31, 2024.
Current paragraph (b) is deleted.
Current paragraph (c) is redesignated
as paragraph (b) and is amended to
reflect that current paragraph (d) has
been deleted and to extend the COVID–
19 telemedicine prescribing flexibilities
through December 31, 2025, provided
all the conditions listed in current
paragraph (e) are met.
Current paragraph (d) is deleted.
Current paragraph (e) is redesignated
as paragraph (c) and is amended to
reflect that current paragraphs (b) and
(d) have been deleted.
DEA and HHS are using the revise
and republish instruction to reflect
these changes as parts of newly
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redesignated paragraph (c) are not
changing.
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.’’ 10
As discussed earlier, DEA, jointly
with HHS, is publishing this third
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
reduced 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 second extension expires on
December 31, 2024. Further, the
reduction in access to care that patients
would experience if the existing
telemedicine flexibilities ended on
December 31, 2024 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, in March 2023, DEA
received 38,369 comments on two
proposed rules regarding the flexibilities
that would be extended by this rule.
DEA considered those comments in
publishing the First Temporary Rule
and Second Temporary Rule.11
Moreover, any final rule or rules that
DEA and, for rules that must be issued
jointly, HHS promulgate addressing
telemedicine more generally would
reflect viewpoints and information from
comments received in response to the
proposed rules, the Telemedicine
Listening Sessions, the Tribal
Consultations, the E.O. 12866 meetings,
and any further comments that may be
collected during additional rounds of
public comment. Because DEA and, for
rules that must be issued jointly, HHS
continue to consider information that
10 5
U.S.C. 553(b)(B).
FR 30037 (May 10, 2023) and 88 FR 69879
(October 10, 2023).
11 88
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was provided in those comments and
presentations, 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.
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 Third Temporary Rule was
developed in accordance with the
principles of 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.
The economic, interagency,
budgetary, legal, and policy
implications of this temporary 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 OMB for review.
DEA, jointly with HHS, is publishing
this Third 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 of the
COVID–19 flexibilities until December
31, 2025, 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 proposed rules set forth in the
March 2023 NPRMs.
Without this Third Temporary Rule,
the COVID–19 PHE telemedicine
flexibilities are scheduled to expire on
December 31, 2024. This rule extends
the expiration of those flexibilities
through December 31, 2025. Because
this rule does not create or remove any
regulatory requirements, DEA and HHS
estimate that there is no cost associated
with this Third Temporary Rule.
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However, 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, similar to
those described in the General
Telemedicine NPRM. However, DEA is
unable to quantify the cost savings and
reduction in transfer payments.
Executive Order 12988, Civil Justice
Reform
The Third 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 Third 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 Third 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
March 2023 NPRMs may have Tribal
implications, consistent with the
definition in E.O. 13175. As such, DEA
engaged in virtual consultations with
numerous Tribal governments and
organizations on June 13 and 27, 2024.
DEA plans to incorporate the concerns
raised during those virtual consultations
when a final set of regulations is
promulgated.
Regulatory Flexibility Act
The Administrator, in accordance
with the Regulatory Flexibility Act (5
U.S.C. 601–612) (RFA), has reviewed
this Third Temporary Rule and by
approving it certifies that it will not
have a significant economic impact on
a substantial number of small entities.
This Third 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.
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Without this Third Temporary Rule,
the COVID–19 PHE telemedicine
flexibilities would expire on December
31, 2024. While this Third Temporary
Rule does not create or remove any
regulatory requirements, this Third
Temporary Rule extends the expiration
of those flexibilities through December
31, 2025. 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.
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).12
However, pursuant to the CRA, DEA is
submitting a copy of this temporary rule
to both Houses of Congress and to the
Comptroller General.
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.
12 5
U.S.C. 804(2).
E:\FR\FM\19NOR1.SGM
19NOR1
Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Rules and Regulations
(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.
List of Subjects
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1307
Administrative practice and
procedure, Drug traffic control,
Prescription drugs.
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 12
Administrative practice and
procedure, Drug traffic control,
Prescription drugs.
PART 12—TELEMEDICINE
FLEXIBILITIES
Drug Enforcement Administration
For the reasons set out above, the
Drug Enforcement Administration
amends 21 CFR part 1307 as follows:
1. The authority citation for part 12
continues to read as follows:
■
Authority: 21 U.S.C. 802(54)(G).
PART 1307—MISCELLANEOUS
2. Revise and republish § 12.1 to read
as follows:
1. The authority citation for part 1307
continues to read as follows:
§ 12.1 Temporary extension of certain
COVID–19 telemedicine flexibilities for
prescription of controlled medications.
Authority: 21 U.S.C. 821, 822(d), 871(b),
unless otherwise noted.
(a) This section is in effect until the
end of the day December 31, 2025. The
authorization granted in paragraph (b) of
this section expires at the end of
December 31, 2025.
(b) During the period May 12, 2023,
through December 31, 2025, 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.
■
■
2. Revise and republish § 1307.41 to
read as follows:
■
ddrumheller on DSK120RN23PROD with RULES1
§ 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, 2025. The
authorization granted in paragraph (b) of
this section expires at the end of
December 31, 2025.
(b) During the period May 12, 2023,
through December 31, 2025, a DEAregistered 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
VerDate Sep<11>2014
15:47 Nov 18, 2024
Jkt 265001
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
91257
Signing Authority
This document of the Drug
Enforcement Administration and the
Department of Health and Human
Services was signed on November 14,
2024, by DEA Administrator Anne
Milgram and the HHS Assistant
Secretary for Mental Health and
Substance Use. Those documents with
the original signatures and dates are
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.
Miriam E. Delphin-Rittmon,
Assistant Secretary for Mental Health and
Substance Use, Department of Health and
Human Services.
[FR Doc. 2024–27018 Filed 11–15–24; 4:15 pm]
BILLING CODE 4410–09–P
DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
30 CFR Part 926
[SATS No. MT–040–FOR; Docket No. OSM–
2023–0001; S1D1S SS08011000 SX064A000
231S180110; S2D2S SS08011000
SX064A000 23XS501520]
Montana Regulatory Program/
Reclamation Plan
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Final rule; approving, in part.
AGENCY:
We, the Office of Surface
Mining Reclamation and Enforcement
(OSMRE), are approving, in part, an
amendment to the Montana regulatory
program under the Surface Mining
Control and Reclamation Act of 1977
(SMCRA or the Act). During the 2019
legislative session, Montana updated its
Montana Strip and Underground Mine
Reclamation Act codified in the
Montana Code Annotated. Accordingly,
Montana submitted this amendment to
OSMRE on its own initiative. The
amendment requires a permit
applicant’s compliance information to
be updated and approved if a
bankruptcy or reorganization results in
SUMMARY:
E:\FR\FM\19NOR1.SGM
19NOR1
]]>Agencies
[Federal Register Volume 89, Number 223 (Tuesday, November 19, 2024)]
[Rules and Regulations]
[Pages 91253-91257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27018]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1307
[Docket No. DEA-407]
RIN 1117-AB40, 1117-AB78, and 1117-ZA06
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 12
Third 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.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) in concert with the
Department of Health and Human Services (HHS) is issuing a third
extension of telemedicine flexibilities for the prescribing of
controlled medications, through December 31, 2025.
DATES: This rule is effective January 1, 2025, through December 31,
2025.
FOR FURTHER INFORMATION CONTACT: Heather E. Achbach, 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
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
A March 31, 2020 ``Dear Registrant'' letter signed by
Thomas W. Prevoznik, DEA's then-Deputy Assistant
[[Page 91254]]
Administrator, Diversion Control Division (the Prevoznik Letter).\2\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 NPRM) and ``Expansion of Induction of
Buprenorphine via Telemedicine Encounter'' \4\ (the Buprenorphine
NPRM)--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 NPRM and 2,915 comments on the
Buprenorphine NPRM. Many of those comments requested changes of varying
degrees to the proposed regulations in the two March 2023 NPRMs.
---------------------------------------------------------------------------
\3\ 88 FR 12875 (Mar. 1, 2023).
\4\ 88 FR 12890 (Mar. 1, 2023).
---------------------------------------------------------------------------
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 (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 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
established a telemedicine relationship on 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.
---------------------------------------------------------------------------
\5\ Temporary Extension of COVID-19 Telemedicine Flexibilities
for Prescription of Controlled Medications, 88 FR 30037 (May 10,
2023).
---------------------------------------------------------------------------
On August 7, 2023, DEA announced that it would host Telemedicine
Listening Sessions on September 12 and 13, 2023, in order 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. On October 10, 2023, DEA, jointly with
HHS, issued a second temporary extension (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.\6\ This extension authorized
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 was effectively subsumed by this Second
Temporary Rule, which continued 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.
---------------------------------------------------------------------------
\6\ Second Temporary Extension of COVID-19 Telemedicine
Flexibilities for Prescription of Controlled Medications, 88 FR
69879 (October 10, 2023).
---------------------------------------------------------------------------
On June 13 and 27, 2024, DEA held virtual Tribal Consultations with
numerous Tribal governments and organizations in order to elicit
further comment from interested Tribal parties regarding the
prescribing of controlled medications via telemedicine and its impact
on Tribal persons. Additionally, in June 2024, DEA transmitted a new
draft telemedicine NPRM to the Office of Management and Budget (OMB)
for review under Executive Order (E.O.) 12866. Since then, DEA has also
attended several meetings with interested parties coordinated by OMB
pursuant to E.O. 12866, which have provided interested parties with the
opportunity to provide further views to OMB.
With the deadline of December 31, 2024, granted by the Second
Temporary Rule quickly approaching, DEA, jointly with HHS, is now
issuing a third temporary extension (Third Temporary Rule) to ensure a
smooth transition for patients and practitioners that have come to rely
on the availability of telemedicine for controlled medication
prescriptions. This additional time will allow DEA (and also HHS, for
rules that must be issued jointly) to promulgate proposed and final
regulations that are consistent with public health and safety, and that
also effectively mitigate the risk of possible diversion. Furthermore,
this Third Temporary Rule will allow adequate time for providers to
come into compliance with any new standards or safeguards eventually
adopted in a final set of regulations. DEA remains committed to
carefully evaluating the comments received in response to the prior
NPRMs, as well as the information and perspectives presented at the
Telemedicine Listening Sessions, the Tribal Consultations, and the E.O.
12866 meetings.
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.\7\ 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.\8\
---------------------------------------------------------------------------
\7\ 21 U.S.C. 829(e).
\8\ 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.
---------------------------------------------------------------------------
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.'' \9\
---------------------------------------------------------------------------
\9\ 21 U.S.C. 802(54)(G).
---------------------------------------------------------------------------
Pursuant to this authority, DEA, jointly with HHS, is hereby
promulgating this Third Temporary Rule specifying certain circumstances
under which practitioners may
[[Page 91255]]
prescribe controlled medications, for the time period described above,
to patients whom the practitioner has never evaluated in person. This
Third Temporary Rule, like the First and Second 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, 2025, 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, for rules that must be issued
jointly, HHS anticipate implementing a final set of regulations that
are consistent with the 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 Second
Temporary Rule and the additional consideration of the input received
during the Telemedicine Listening Sessions, the Tribal Consultations,
and the E.O. 12866 meetings, DEA, jointly with HHS, has elected to
again extend those flexibilities to maintain access to care during a
limited window of time as the agencies 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, DEA and
HHS have determined that this Third 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).
Thus, DEA, jointly with HHS, is promulgating this temporary rule
pursuant to 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 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 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;
Address the urgent public health need for continued access
to 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 to continue considering the presentations made
at the Telemedicine Listening Sessions, the Tribal Consultations, and
the E.O. 12866 meetings;
Enable DEA, with HHS for rules that must be issued
jointly, 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 the 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 third extension of flexibilities
to a short, time-limited period.
IV. Summary of Third Temporary Rule Changes
This Third Temporary Rule amends portions of 21 CFR 1307.41 and 42
CFR 12.1 through December 31, 2025.
Paragraph (a) is amended to state that the authorization granted in
the amended paragraph (c) expires at the end of December 31, 2025,
instead of December 31, 2024.
Current paragraph (b) is deleted.
Current paragraph (c) is redesignated as paragraph (b) and is
amended to reflect that current paragraph (d) has been deleted and to
extend the COVID-19 telemedicine prescribing flexibilities through
December 31, 2025, provided all the conditions listed in current
paragraph (e) are met.
Current paragraph (d) is deleted.
Current paragraph (e) is redesignated as paragraph (c) and is
amended to reflect that current paragraphs (b) and (d) have been
deleted.
DEA and HHS are using the revise and republish instruction to
reflect these changes as parts of newly redesignated paragraph (c) are
not changing.
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.'' \10\
---------------------------------------------------------------------------
\10\ 5 U.S.C. 553(b)(B).
---------------------------------------------------------------------------
As discussed earlier, DEA, jointly with HHS, is publishing this
third 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 reduced 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 second
extension expires on December 31, 2024. Further, the reduction in
access to care that patients would experience if the existing
telemedicine flexibilities ended on December 31, 2024 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, in March 2023, DEA received 38,369 comments on two
proposed rules regarding the flexibilities that would be extended by
this rule. DEA considered those comments in publishing the First
Temporary Rule and Second Temporary Rule.\11\ Moreover, any final rule
or rules that DEA and, for rules that must be issued jointly, HHS
promulgate addressing telemedicine more generally would reflect
viewpoints and information from comments received in response to the
proposed rules, the Telemedicine Listening Sessions, the Tribal
Consultations, the E.O. 12866 meetings, and any further comments that
may be collected during additional rounds of public comment. Because
DEA and, for rules that must be issued jointly, HHS continue to
consider information that
[[Page 91256]]
was provided in those comments and presentations, 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.
---------------------------------------------------------------------------
\11\ 88 FR 30037 (May 10, 2023) and 88 FR 69879 (October 10,
2023).
---------------------------------------------------------------------------
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 Third Temporary Rule was developed in accordance with the
principles of 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.
The economic, interagency, budgetary, legal, and policy
implications of this temporary 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 OMB for review.
DEA, jointly with HHS, is publishing this Third 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 of the
COVID-19 flexibilities until December 31, 2025, 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 proposed rules set forth in the
March 2023 NPRMs.
Without this Third Temporary Rule, the COVID-19 PHE telemedicine
flexibilities are scheduled to expire on December 31, 2024. This rule
extends the expiration of those flexibilities through December 31,
2025. Because this rule does not create or remove any regulatory
requirements, DEA and HHS estimate that there is no cost associated
with this Third Temporary Rule. However, 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,
similar to those described in the General Telemedicine NPRM. However,
DEA is unable to quantify the cost savings and reduction in transfer
payments.
Executive Order 12988, Civil Justice Reform
The Third 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 Third 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 Third 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 March 2023 NPRMs may have
Tribal implications, consistent with the definition in E.O. 13175. As
such, DEA engaged in virtual consultations with numerous Tribal
governments and organizations on June 13 and 27, 2024. DEA plans to
incorporate the concerns raised during those virtual consultations when
a final set of regulations is promulgated.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act (5 U.S.C. 601-612) (RFA), has reviewed this Third Temporary Rule
and by approving it certifies that it will not have a significant
economic impact on a substantial number of small entities. This Third
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 Third Temporary Rule, the COVID-19 PHE telemedicine
flexibilities would expire on December 31, 2024. While this Third
Temporary Rule does not create or remove any regulatory requirements,
this Third Temporary Rule extends the expiration of those flexibilities
through December 31, 2025. 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.
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).\12\ However, pursuant to the
CRA, DEA is submitting a copy of this temporary rule to both Houses of
Congress and to the Comptroller General.
---------------------------------------------------------------------------
\12\ 5 U.S.C. 804(2).
---------------------------------------------------------------------------
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.
[[Page 91257]]
List of Subjects
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1307
Administrative practice and procedure, Drug traffic control,
Prescription drugs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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,
2025. The authorization granted in paragraph (b) of this section
expires at the end of December 31, 2025.
(b) During the period May 12, 2023, through December 31, 2025, 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
0
1. The authority citation for part 12 continues to read as follows:
Authority: 21 U.S.C. 802(54)(G).
0
2. 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,
2025. The authorization granted in paragraph (b) of this section
expires at the end of December 31, 2025.
(b) During the period May 12, 2023, through December 31, 2025, 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 and the
Department of Health and Human Services was signed on November 14,
2024, by DEA Administrator Anne Milgram and the HHS Assistant Secretary
for Mental Health and Substance Use. Those documents with the original
signatures and dates are 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.
Miriam E. Delphin-Rittmon,
Assistant Secretary for Mental Health and Substance Use, Department of
Health and Human Services.
[FR Doc. 2024-27018 Filed 11-15-24; 4:15 pm]
BILLING CODE 4410-09-P
