Federal Register, Volume 88 Issue 194 (Tuesday, October 10, 2023)

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

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1307

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 12

Second Temporary Extension of COVID-19 Telemedicine Flexibilities
for Prescription of Controlled Medications

AGENCY: Drug Enforcement Administration, Department of Justice;
Substance Abuse and Mental Health Services Administration, Department
of Health and Human Services.

ACTION: Temporary rule.

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

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

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

SUPPLEMENTARY INFORMATION:

I. Background

Overview

Under the Ryan Haight Online Pharmacy Consumer Protection Act of
2008 (the Ryan Haight Act), a prescribing practitioner--subject to
certain exceptions--may prescribe controlled medications to a patient
only after conducting an in-person evaluation of that patient. In
response to the COVID-19 Public Health Emergency (COVID-19 PHE), as
declared by the Secretary (the Secretary) of the Department of Health
and Human Services (HHS) on January 31, 2020, pursuant to the authority
under section 319 of the Public Health Service Act (42 U.S.C. 247), the
Drug Enforcement Administration (DEA) granted temporary exceptions to
the Ryan Haight Act and DEA's implementing regulations under 21 U.S.C.
802(54)(D).
In order to prevent lapses in care, these exceptions allowed for
the prescribing of controlled medications via telemedicine encounters
even when the prescribing practitioner had not conducted an in-person
medical evaluation of the patient. These telemedicine flexibilities
authorized practitioners to prescribe schedule II-V controlled
medications via audio-video telemedicine encounters, including schedule
III-V narcotic controlled medications approved by the Food and Drug
Administration (FDA) for maintenance and withdrawal management
treatment of opioid use disorder via audio-only telemedicine
encounters, provided that such prescriptions otherwise comply with the
requirements outlined in DEA guidance documents, DEA regulations, and
applicable Federal and State law. DEA granted those temporary
exceptions to the Ryan Haight Act and DEA's implementing regulations
via two letters published in March 2020:
A March 25, 2020 ``Dear Registrant'' letter signed by
William T. McDermott, DEA's then-Assistant Administrator, Diversion
Control Division (the McDermott Letter); \1\ and
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\1\ William T. McDermott, DEA Dear Registrant letter, Drug
Enforcement Administration (March 25, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.

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[[Page 69880]]

A March 31, 2020 ``Dear Registrant'' letter signed by
Thomas W. Prevoznik, DEA's then-Deputy Assistant Administrator,
Diversion Control Division (the Prevoznik Letter).\2\
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\2\ Thomas W. Prevoznik, DEA Dear Registrant letter, Drug
Enforcement Administration (March 31, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Fina
l)%20+Esign.pdf.
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On March 1, 2023, DEA, in concert with HHS, promulgated two notices
of proposed rulemaking (NPRMs) in the Federal Register--``Telemedicine
Prescribing of Controlled Substances When the Practitioner and the
Patient Have Not Had a Prior In-Person Medical Evaluation'' \3\ (the
General Telemedicine Rule) and ``Expansion of Induction of
Buprenorphine via Telemedicine Encounter'' \4\ (the Buprenorphine
Rule)--which proposed to expand patient access to prescriptions for
controlled medications via telemedicine encounters relative to the pre-
COVID-19 PHE landscape. The purpose of the two proposed rules was to
make permanent some of the telemedicine flexibilities established
during the COVID-19 PHE in order to facilitate patient access to
controlled medications via telemedicine when consistent with public
health and safety, while maintaining effective controls against
diversion. The comment period for these two NPRMs closed on March 31,
2023. Those NPRMs generated a total of 38,369 public comments--35,454
comments on the General Telemedicine Rule and 2,915 comments on the
Buprenorphine Rule.
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\3\ 88 FR 12875 (Mar. 1, 2023).
\4\ 88 FR 12890 (Mar. 1, 2023).
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On May 10, 2023 DEA, jointly with HHS (with the Substance Abuse and
Mental Health Services Administration (SAMHSA) acting on behalf of
HHS), issued the First Temporary Rule, which extended the full set of
telemedicine flexibilities regarding the prescribing of controlled
medications, as had been in place under the COVID-19 PHE, through
November 11, 2023.\5\ The First Temporary Rule also provided a one-year
grace period, through November 11, 2024, to any practitioner-patient
telemedicine relationships that have been or will be established on or
before November 11, 2023. In other words, under the First Temporary
Rule, if a patient and a practitioner have established a telemedicine
relationship on or before November 11, 2023, the same telemedicine
flexibilities that have governed the relationship to that point would
continue to apply through November 11, 2024.
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\5\ Temporary Extension of COVID-19 Telemedicine Flexibilities
for Prescription of Controlled Medications, 88 FR 30037 (May 10,
2023).
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On August 7, 2023, DEA announced that it would host Telemedicine
Listening Sessions on September 12 and 13, 2023 to receive additional
input concerning the practice of telemedicine with regards to
prescribing controlled medications and potential safeguards that could
effectively prevent and detect diversion of controlled substances
prescribed via telemedicine. DEA is carefully evaluating the
information and perspectives presented at the Telemedicine Listening
Sessions, as well as the comments received in response to the NPRMs, as
DEA and HHS develop regulations providing access to the practice of
telemedicine when consistent with public health and safety, and that
also effectively mitigate the risk of possible diversion.
In light of the need to further evaluate the best course of action
given the comments received in response to the NPRMs and the
presentations at the Telemedicine Listening Sessions, DEA, jointly with
HHS, is issuing this second temporary rule (``Second Temporary Rule'')
extending the full set of telemedicine flexibilities regarding
prescription of controlled medications as were in place during the
COVID-19 PHE, through December 31, 2024. This extension authorizes all
DEA-registered practitioners to prescribe schedule II-V controlled
medications via telemedicine through December 31, 2024, whether or not
the patient and practitioner established a telemedicine relationship on
or before November 11, 2023. In other words, the grace period provided
in the First Temporary Rule is effectively subsumed by this Second
Temporary Rule, which continues the extension of the current
flexibilities for all practitioner-patient relationships--not just
those established on or before November 11, 2023--until the end of
2024.
The purpose of this Second Temporary Rule, like the one before it,
is to ensure a smooth transition for patients and practitioners that
have come to rely on the availability of telemedicine for controlled
medication prescriptions, as well as allowing adequate time for
providers to come into compliance with any new standards or safeguards.
DEA is working to promulgate new standards or safeguards by the fall of
2024.

II. Legal Authority

The Ryan Haight Act amended the Controlled Substances Act (CSA) to
generally require that the dispensing of controlled medications by
means of the internet be predicated on a valid prescription involving
at least one in-person medical evaluation.\6\ At the same time, it also
established excepted categories of telemedicine pursuant to which a
practitioner may prescribe controlled medications for a patient despite
never having evaluated that patient in person, provided that, among
other things, such practice is in accordance with applicable Federal
and State laws.\7\
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\6\ 21 U.S.C. 829(e).
\7\ 21 U.S.C. 802(54)(A)-(G). The Attorney General has delegated
his rulemaking authority under this provision to the Administrator
of DEA via 28 CFR 0.100. The Secretary delegated his rulemaking
authority under 21 U.S.C. 802(54)(G) to the Assistant Secretary for
Mental Health and Substance Use within the Substance Abuse and
Mental Health Services Administration on May 4, 2023.
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One of these categories authorizes the Attorney General and the
Secretary to jointly promulgate rules that would allow practitioners to
prescribe medications for patients via telemedicine without having had
an in-person evaluation when such telemedicine practice is in
accordance with applicable Federal and State laws, uses an approved
telecommunications system, and is ``conducted under . . . circumstances
that the[y have] . . . determined to be consistent with effective
controls against diversion and otherwise consistent with the public
health and safety.'' \8\
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\8\ 21 U.S.C. 802(54)(G).
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Pursuant to this authority, DEA, jointly with HHS, is hereby
promulgating this Second Temporary Rule specifying certain
circumstances under which practitioners may prescribe controlled
medications, for the time period described above, to patients whom the
practitioner has never evaluated in person. This Second Temporary Rule,
like the First Temporary Rule, covers the portions of the NPRM related
to extensions of the telemedicine flexibilities in place during the
COVID-19 PHE, and it extends, through December 31, 2024, the
telemedicine flexibilities that have been in place since March 2020 for
prescribing controlled medications via the practice of telemedicine.
As noted previously, DEA and/or HHS anticipate implementing a final
set of regulations providing access to the practice of telemedicine
when consistent with public health and safety, and that also
effectively mitigate the risk of possible diversion. However, given the
impending expiration of the flexibilities provided in the First
Temporary Rule and the additional

[[Page 69881]]

consideration of the input received during the Telemedicine Listening
Sessions, DEA, jointly with HHS, has elected to again extend those
flexibilities to maintain access to care during a limited window of
time as they consider the appropriate pathway forward.
As explained further below, because this is an extension of limited
duration of flexibilities that existed during the COVID-19 PHE, and
because there are legitimate concerns regarding patient access to care
following the expiration the practitioner-patient relationship aspect
of the First Temporary Rule on November 11, 2023, DEA and HHS have
determined that this Second Temporary Rule is consistent ``with
effective controls against diversion and otherwise consistent with the
public health and safety'' as required under 21 U.S.C. 802(54)(G). DEA,
jointly with HHS, is promulgating this temporary rule pursuant to 21
U.S.C. 802(54)(G).
HHS also has advised DEA that no additional rulemaking by HHS is
necessary as it pertains to the promulgation of these provisions
pursuant to 21 U.S.C. 802(54)(G).

III. Purpose and Need for Regulatory Changes

The purpose of this rulemaking is to further extend, for a limited
period of time, the telemedicine flexibilities that existed during the
COVID-19 PHE in order to:
Prevent a reduction in access to care for patients who do
not yet have an existing telemedicine relationship with their
practitioners pending promulgation of a final rule or rules addressing
telemedicine more generally.
For relationships established both during the COVID-19 PHE
and those established shortly after, prevent backlogs with respect to
in-person medical evaluations in the months shortly before and after
the expiration of the telemedicine flexibilities and ensure the
availability of telemedicine for practitioners and patients who have
come to rely on it;
Address the urgent public health need for continued access
to the initiation of buprenorphine as medication for opioid use
disorder in the context of the continuing opioid public health crisis;
Allow patients, practitioners, pharmacists, service
providers, and other stakeholders sufficient time to prepare for the
implementation of any future regulations that apply to prescribing of
controlled medications via telemedicine;
Enable DEA and potentially HHS to thoroughly consider the
presentations made at the Telemedicine Listening Sessions;
Enable DEA, jointly with HHS, to conduct a thorough
evaluation of regulatory alternatives in order to promulgate
regulations that most effectively expand access to telemedicine
encounters in a manner that is consistent with public health and
safety, while also effectively mitigating against the risk of possible
diversion; and
Avoid incentivizing the investment necessary to develop
new telemedicine companies that might encourage or enable problematic
prescribing practices by limiting the second extension of flexibilities
to a short, time-limited period.

IV. Summary of Second Temporary Rule Changes

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

V. Regulatory Analyses

Administrative Procedure Act

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

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

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

[[Page 69882]]

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

Executive Order 12988, Civil Justice Reform

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

Executive Order 13132, Federalism

This Second Temporary Rule does not have federalism implications
warranting the application of E.O. 13132. The rule does not have
substantial direct effects on the states, on the relationship between
the National Government and the States, or the distribution of power
and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments

This Second Temporary Rule does not have substantial direct effects
on the Tribes, on the relationship between the National Government and
the Tribes, or the distribution of power and responsibilities between
the Federal Government and Indian Tribes.

Regulatory Flexibility Act

The Administrator, in accordance with the Regulatory Flexibility
Act (5 U.S.C. 601-612) (RFA), has reviewed this Second Temporary Rule
and by approving it certifies that it will not have a significant
economic impact on a substantial number of small entities. This Second
Temporary Rule, as discussed above, merely extends for a limited time
the status quo with respect to the current flexibilities allowed during
the COVID-19 PHE, in order to avoid lapses in coverage for patients.
Without this Second Temporary Rule, COVID-19 PHE telemedicine
flexibilities would expire on November 11, 2023, with respect to
practitioner-patient relationships established after that date. While
this Second Temporary Rule does not create or remove any regulatory
requirements, this Second Temporary Rule extends the expiration of
those flexibilities through December 31, 2024. DEA and HHS believe this
extension create a benefit in form of cost savings to prescribers and
patients and reduced transfer payments to the Federal Government.
In accordance with the RFA, DEA will be evaluating the impact on
small entities at the time the final rule or rules are issued as part
of these rulemakings.

Paperwork Reduction Act of 1995

This temporary rule will not impose a new collection or modify an
existing collection of information under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501-3521). Also, this temporary rule does not impose
recordkeeping or reporting requirements on State or local governments,
individuals, businesses, or other organizations. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a valid OMB control
number.

Congressional Review Act

This temporary rule is not a major rule as defined by Subtitle E of
the Small Business Regulatory Enforcement Fairness Act of 1996 (known
as the Congressional Review Act or CRA).\11\ However, pursuant to the
CRA, DEA is submitting a copy of this temporary rule to both Houses of
Congress and to the Comptroller General.
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\11\ 5 U.S.C. 804(2).
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Signing Authority

This document of the Drug Enforcement Administration and the
Department of Health and Human Services was signed on October 4, 2023,
by DEA Administrator Anne Milgram. Those documents with the original
signatures and dates is maintained by DEA. For administrative purposes
only, and in compliance with requirements of the Office of the Federal
Register, the undersigned DEA Federal Register Liaison Officer has been
authorized to sign and submit the document in electronic format for
publication, as an official document of DEA. This administrative
process in no way alters the legal effect of this document upon
publication in the Federal Register.

List of Subjects

21 CFR Part 1307

Administrative practice and procedure, Drug traffic control,
Prescription drugs.

42 CFR Part 12

Administrative practice and procedure, Drug traffic control,
Prescription drugs.

21 CFR Chapter II

For the reasons set out above, the Drug Enforcement Administration
amends 21 CFR part 1307 as follows:

PART 1307--MISCELLANEOUS

0
1. The authority citation for part 1307 continues to read as follows:

Authority: 21 U.S.C. 821, 822(d), 871(b), unless otherwise
noted.

0
2. Amend Sec. 1307.41 by revising paragraphs (a) and (c) to read as
follows:

Sec. 1307.41 Temporary extension of certain COVID-19 telemedicine
flexibilities for prescription of controlled medications.

[[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]
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