Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 69879-69883 [2023-22406]
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Federal Register / Vol. 88, No. 194 / Tuesday, October 10, 2023 / Rules and Regulations
www.regulations.gov. A 30-day
comment period ending July 17, 2023,
was provided for interested persons to
respond to the proposal. No comments
were received. Accordingly, no changes
have been made to the rule as proposed.
A small business guide on complying
with fruit, vegetable, and specialty crop
marketing agreements and orders may
be viewed at: https://
www.ams.usda.gov/rules-regulations/
moa/small-businesses. Any questions
about the compliance guide should be
sent to Richard Lower at the previously
mentioned address in the FOR FURTHER
INFORMATION CONTACT section.
After consideration of all relevant
material presented, including the
information and recommendations
submitted by the Committee and other
available information, AMS has
determined that this rule tends to
effectuate the declared policy of the Act.
DEPARTMENT OF JUSTICE
List of Subjects in 7 CFR Part 956
SUMMARY:
Marketing agreements, Onions,
Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, the Agricultural Marketing
Service amends 7 CFR part 956 as
follows:
PART 956—SWEET ONIONS GROWN
IN THE WALLA WALLA VALLEY OF
SOUTHEAST WASHINGTON AND
NORTHEAST OREGON
1. The authority citation for 7 CFR
part 956 continues to read as follows:
■
Authority: 7 U.S.C. 601–674.
■
2. Revise § 956.202 to read as follows:
§ 956.202
Assessment rate.
On and after January 1, 2023, an
assessment rate of $0.20 per 50-pound
bag or equivalent is established for
Walla Walla sweet onions.
Erin Morris,
Associate Administrator, Agricultural
Marketing Service.
[FR Doc. 2023–22331 Filed 10–6–23; 8:45 am]
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BILLING CODE P
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Drug Enforcement Administration
21 CFR Part 1307
[Docket No. DEA–407]
RIN 1117–AB40 and 1117–AB78
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Overview
Second 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:
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 inperson 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 practitionerpatient 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 practitionerpatient 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
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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
42 CFR Part 12
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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,
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• A March 31, 2020 ‘‘Dear Registrant’’
letter signed by Thomas W. Prevoznik,
DEA’s then-Deputy Assistant
Administrator, Diversion Control
Division (the Prevoznik Letter).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
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.
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 oneyear 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
2020), https://www.deadiversion.usdoj.gov/GDP/
(DEA-DC-018)(DEA067)%20DEA%20state
%20reciprocity%20(final)(Signed).pdf.
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(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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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.
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
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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.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
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.’’ 8
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
6 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.
8 21 U.S.C. 802(54)(G).
7 21
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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
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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
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
95
PO 00000
U.S.C. 553(b)(B).
Frm 00009
Fmt 4700
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.
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.
10 88
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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
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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 practitionerpatient 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.
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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.
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
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.
2. Amend § 1307.41 by revising
paragraphs (a) and (c) to read as follows:
■
§ 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 DEA11 5
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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.
*
*
*
*
*
Empowering Broadband Consumers
Through Transparency
3. The authority citation for part 12
continues to read as follows:
■
Authority: 21 U.S.C. 802(54)(G).
4. Amend § 12.1 by revising the
section heading and paragraphs (a) and
(c) to read as follows:
■
§ 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
Jkt 262001
In this document, the
Commission announces the compliance
dates for the rules implementing the
Infrastructure Investment and Jobs Act
per the Broadband Label Order. The
rules require broadband internet access
service providers (providers) to display,
at the point of sale, labels that disclose
certain information about broadband
prices, introductory rates, data
allowances, and broadband speeds, and
to include links to information about
their network management practices,
privacy policies, and the Commission’s
Affordable Connectivity Program.
DATES:
Effective date: October 10, 2023.
Compliance dates: Compliance with
47 CFR 8.1(a)(1), (a)(2), (a)(4) through
(a)(6), published at 87 FR 76959
(December 16, 2022) and amended at 88
FR 52043 (August 7, 2023) and 88 FR
63853 (September 18, 2023), for
providers with 100,000 or fewer
subscriber lines is required as of
October 10, 2024 and for all other
providers is required as of April 10,
2024, except that compliance with the
requirement in 47 CFR 8.1(a)(2) to make
labels accessible in online account
portals will not be required for all
providers until October 10, 2024.
Compliance with 47 CFR 8.1(a)(3) is
required for all providers as of October
10, 2024. The Commission will publish
a document in the Federal Register
revising 47 CFR 8.1 to incorporate these
compliance dates.
FOR FURTHER INFORMATION CONTACT:
Erica H. McMahon of the Consumer and
Governmental Affairs Bureau, Consumer
Policy Division, at (202) 418–0346 or
Erica.McMahon@fcc.gov.
SUPPLEMENTARY INFORMATION: This
document announces that the Office of
Management and Budget approved the
information collection requirements in
§§ 8.1(a)(1) through (a)(6) and (b) on
September 19, 2023. The Commission
publishes this document as an
announcement of the compliance dates
of the rules. In an Order on
Reconsideration published at 88 FR
SUMMARY:
PART 12—TELEMEDICINE
FLEXIBILITIES
ddrumheller on DSK120RN23PROD with RULES1
[CG Docket No. 22–2; FCC 22–86; DA 23–
617; FCC 23–68; FR ID 175318]
Federal Communications
Commission.
ACTION: Final rule; announcement of
compliance dates.
For the reasons set out above, the
Department of Health and Human
Services amends 42 CFR part 12 as
follows:
16:24 Oct 06, 2023
47 CFR Part 8
AGENCY:
42 CFR Chapter I
VerDate Sep<11>2014
FEDERAL COMMUNICATIONS
COMMISSION
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
69883
63853 (September 18, 2023), the
Commission affirmed its determinations
that providers must itemize monthly
discretionary fees on the label and state
how much data is provided with the
service plan, as outlined by the label
template. It also clarified that the
requirement to document interactions
with consumers at alternate sales
channels will be deemed satisfied if,
instead, the provider establishes the
business practices and processes it will
follow in distributing the label through
alternative sales channels; retains
training materials and related business
practice documentation for two years;
and provides such information to the
Commission upon request, within 30
days. The Commission also determined
that wireless providers have the
flexibility to state ‘‘taxes included’’ or
add similar language to the label
template when the provider has chosen
to include taxes as part of its base price.
In addition, the Commission affirmed its
determination in the Broadband Label
Order that ‘‘enterprise service offerings
or special access services are not ‘massmarket retail services,’ and therefore,
not covered by our label requirement.’’
To request materials in accessible
formats for people with disabilities
(Braille, large print, electronic files,
audio format), send an email to fcc504@
fcc.gov or call the Consumer and
Governmental Affairs Bureau at (202)
418–0530 (voice).
Federal Communications Commission.
Marlene Dortch,
Secretary.
[FR Doc. 2023–21682 Filed 10–5–23; 4:15 pm]
BILLING CODE 6712–01–P
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
48 CFR Parts 1801, 1819, and 1852
RIN 2700–AE65
NASA Federal Acquisition Regulation
Supplement: NASA Mentor-Prote´ge´
Program
National Aeronautics and
Space Administration (NASA).
ACTION: Final rule.
AGENCY:
NASA is finalizing
amendments to the NASA Federal
Acquisition Regulation Supplement
(NFS)to reflect updates to NASA’s Small
Business Mentor Prote´ge´ Program
(MPP).
SUMMARY:
DATES:
Effective November 9, 2023.
FOR FURTHER INFORMATION CONTACT:
Todd Lacks, NASA HQ, Office of
E:\FR\FM\10OCR1.SGM
10OCR1
R.
Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
[[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\
---------------------------------------------------------------------------
\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 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.
---------------------------------------------------------------------------
\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 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.
---------------------------------------------------------------------------
\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 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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\8\ 21 U.S.C. 802(54)(G).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\9\ 5 U.S.C. 553(b)(B).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\10\ 88 FR 30037, 30039-30041 (May 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 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.
---------------------------------------------------------------------------
\11\ 5 U.S.C. 804(2).
---------------------------------------------------------------------------
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